1Department of Internal Medicine, Albert Einstein Medical Center, Philadelphia, PA, USA
2Division of Gastroenterology, Hepatology and Nutrition, University of Texas Health Science Center at Houston, Houston, TX, USA
Copyright © 2016 Korean Society of Gastrointestinal Endoscopy
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Study | Country | Study type | Inclusion/exclusion criteria | Intervention to prevent esophaged stricture development | No. of subjects | Timing of intervention | Technique | Dose | Outcome | Complication secondary to intervention or dilation session |
---|---|---|---|---|---|---|---|---|---|---|
Hashimoto et al. (2011) [7] | Japan | Prospective study | Inclusion | Endoscopic triamcinolone injection, 10 mg/mL solution | 21 | Day 3,7 and 10 (post-ESD) | 1. A 25 G, 4 mm needle tos used | Total dose per session (varied with ulcer size): range, 18-62 mg | 1. Stricture rate: 4/21 (19%) | None |
1. Superficial esophageal SCC treated by ESD | 2.1 mL syringe was used to inject manually | 2. No. of required EBD: mean (range), 1.7 (0-15) | ||||||||
2. Mucosal defect involving three fourth of esophageal circumference | 3. Steroid tos injected in aliquots of 0.2 mL, 1 cm apart in semicircumferential fashion | |||||||||
4. No. of injections per session (varied with ulcer size): range, 9-31 | ||||||||||
Historical control group (no intervention) | 20 | NA | NA | NA | 1. Stricture rate: 15/20 (75%) | NA | ||||
2. No. of required EBD: mean (range), 6.6 (0-20) | ||||||||||
Hanaoka et al. (2012) [8] | Japan | Prospective study | Inclusion | Endoscopic Intralesional steroid (TA) injection, diluted with saline to make 5 mg/mL solution | 30 | Day 0 (post-ESD) | 1. A25G needle was used | 100 mg (irrespective of ulcer bed size) | 1. Stricture rate: 3/30 (10%) | Complication rate: 2/30 (7%) |
1. Esophageal SCC treated by ESD | 2. Injected evenly into the residual submucosal tissue of ulcer bed in 0.5-1.0 ml increments (20-40 punctures) | 2. No. of EBD session: median (range), 0 (0-2) | 1. Deep submucosal tear without perforation (during stricture evaluation 2 months post-ESD): 1/2 managed conservatively (fasting) | |||||||
2. Mucosal defect more than three quarter but less than whole circumference | 3. The initial injections were given at the margins of the ulcer and these were followed by linear injections given from the distal side to proximal side of the ulcer margin | |||||||||
3. No lymph node metastases on CT scanning | 4. If muscle layer tos partially exposed post-ESD, steroid injection tos not performed in that area | 2. Esophageal hemorrhage: 1/2 tarry stools (8 days post-ESD)-required endoscopic hemostasis | ||||||||
4. No organ failure | ||||||||||
Exclusion | ||||||||||
1. Active synchronous cancer | ||||||||||
2. Prior radiation therapy for esophageal cancer | ||||||||||
3. Multiple esophageal cancers | ||||||||||
4. Liver cirrhosis | ||||||||||
5. Poorly controlled DM | ||||||||||
6. Mucosal defect involving whole esophageal circumference | ||||||||||
Inclusion | Historical control group (no intervention) | 29 | NA | NA | NA | 1. Stricture rate: 19/29(66%) | NA | |||
1. Superficial esophageal SCC treated byESD | 2. No. of EBD session: median (range), 2 (0-15) | |||||||||
2. Mucosal defect more than three quarter but less than whole circumference | ||||||||||
Exclusion | ||||||||||
1. Active synchronous cancer | ||||||||||
2. Prior radiation therapy for esophageal cancer | ||||||||||
3. Multiple esophageal cancers | ||||||||||
4. Liver cirrhosis | ||||||||||
5. Poorly controlled DM | ||||||||||
Mori et al. (2013) [9] | Japan | Prospective, randomized study | Inclusion | Local steroid injection and balloon dilation | 23 (2 subjects were excluded because of bleeding, see complication section) | Day 5,8,12, and 15 | TA injection (each of 0.2 mL/2 mg) into ulcer floor at 8 mm intervals with extra care to avoid injection into muscularis propria, followed by 5 minutes session of EBD | Range, 62–88 mg of TA | 1. No. of EBD sessions after day 20: mean (range), 4.27 (0-12) | 1. No. of subjects with oaring bleeding before day 15: mean (range), 0.46 (0-2); both of these subjects were on oral anticoagulants and required endoscopic hemostasis |
1. Early esophageal cancer | 2. Procedure time (min): mean (range), 7.33 (5-11) | |||||||||
2. Mucosal defect involving two third to entire circumference | 3. Stricture rate (%): mean±SD | |||||||||
1) Day 5: 78±22 | ||||||||||
2) Day 8: 81±21 | ||||||||||
3) Day 12: 76±24 | ||||||||||
4) Day 15: 82±19 | ||||||||||
5) Day 20: 83±19 | ||||||||||
6) Day 30: 83±16 | ||||||||||
7) Day 60: 81±22 | ||||||||||
Steroid gel application and balloon dilation | 20 | Day 5,8,12, and 15 | 10 mL of TA gel mixed with 7.5 mL of endolubri jelly, applied from distal to proximal end of ulcer with spraying tube via endoscope; followed by 5 minutes session of EBD | 100 mg of TA | 1. No. of EBD sessions after day 20: mean (range), 1.6 (0-5) | None | ||||
2. Procedure time (min): mean (range), 6.87 (6-8) | ||||||||||
3. Stricture rate (%): mean±SD | ||||||||||
1) Day 5: 80±17 | ||||||||||
2) Day 8: 79±18 | ||||||||||
3) Day 12: 82±15 | ||||||||||
4) Day 15: 83±15 | ||||||||||
5) Day 20: 83±13 | ||||||||||
6) Day 30: 85±14 | ||||||||||
7) Day 60: 81±21 | ||||||||||
Takahashi et al. (2015) [10] | Japan | Prospective randomized controlled, open label, single center study | Inclusion | Endoscopic steroid injection therapy | 16 | Day 0 (post-ESD) | 1. TA diluted with 0.9% NaCl to final concentration of 10 mg/mL | NA | 1. Stricture rate: 10/16 (62.5%) | Perforation: 1/97 (1.0%) |
1. Early esophageal SCC | 2. 0.5 mL aliquots injected at ulcer base using 25 G, 3 mm needle | 2. No. of required dilation sessions: mean±SD (range), 6.1±6.2 (0–17) | ||||||||
2. Expected mucosal defect more than three quarter of esophageal circumference | 3. Starting at distal edge, repeated evenly at points 10 mm apart, upto proximal edge | 3. Duration of dilation therapy (mo): mean±SD (range), 3.5±4.0 (0-13) | ||||||||
4. Special precautions to avoid injecting into muscularis propria | 4. Minimum diameter of strictured region (mm): mean±SD (range), 11.0±4.6 (5.4–21.8) | |||||||||
Exclusion | ||||||||||
1. Subjects who received additional adjuvant treatment- surgery or chemoradiation | ||||||||||
2. Subjects who were not regularly or adequately followed up | ||||||||||
None | 16 | NA | NA | NA | 1. Stricture rate: 14/16 (87.5%) | Perforation: 1/200 (0.5%) | ||||
2. No. of required dilation sessions: mean±SD (range), 12.5±10.1 (0–140) | ||||||||||
3. Duration of dilation therapy (mo): mean±SD (range), 6.1±5.0 (0–20) | ||||||||||
4. Minimum diameter of stricture (mm): mean±SD (range), 7.1±2.9 (5.1–12.8) | ||||||||||
Ohki et al. (2012) [11] | Japan | Prospective open label, single arm, single center study | Inclusion | Transplantation of autologous cell sheets to ulcer surfaces via an endoscope | 9 | Day 0 (post-ESD) | The polyvinylidene difluoride support membrane with an attached autologous oral mucosal epithelial cell sheet, grasped by endoscopic forceps and placed over the ulcer site via EMR tube | No. of transplanted cell sheets: range, 2-8; each sheet being 23.4 mm in diameter | Stricture rate: 1/9 (11.1%; the subject had full circumferential mucosal defect extending upto gastroesophageal junction and required EBD 21 times) | High grade fever: 4/9 subjects, no intervention required |
1. Esophageal cancer | ||||||||||
2. Expected mucosal defect post-ESD at least two thirds of esophageal circumference | ||||||||||
Exclusion | ||||||||||
1. DM (HbA1c ≥10) | ||||||||||
2. Corticosteroid use | ||||||||||
3. Undergoing treatment for oral cancer | ||||||||||
4. Receiving radiotherapy for esophageal cancer | ||||||||||
Iizuka et al. (2015) [12] | Japan | Prospective, single center study | Inclusion | MCFP technique | 15 (2 subjects underwent surgical resection at day 20 and 30 post-ESD due to extent of disease) | Day 0 (post-ESD) | 1. Spraying fibrinogen solution at mucosal defect | Mean no. of PGA sheets used: 10 (each sheet was 15×7 mm) | 1. Stricture rate at 6 weeks post-ESD: 1/13 (7.7%) | Bleeding: 1/15- post-ESD, conservatively managed |
1. Superficial esophageal SCC treated by ESD | 2. PGA sheet patches were placed without overlapping | 2. No. of required EBD: 5 times for one patient | ||||||||
2. Mucosal defect involving more than half but less than whole esophageal circumference | 3. Fibrinogen and thrombin solutions were sprayed over the sheets | 3. Dysphagia: 3/13, one had stricture, two had no stricture | ||||||||
Exclusion | ||||||||||
1. History of esophagectomy | ||||||||||
2. History of radiation therapy | ||||||||||
3. A lesion near a scar left after previous endoscopic resection | ||||||||||
4. A lesion suspected preoperatively to be m3 or sml stage | ||||||||||
5. Uncontrolled DM | ||||||||||
6. Current steroid hormone use | ||||||||||
Sakaguchi et al. (2015) [13] | Japan | Prospective pilot study, single arm, single center | Inclusion | PGA sheet deployment with fibrin glue | 8 | Day 0 (post-ESD) | 1. The PGA sheet was deployed using modified version of clip and pull method | Each PGA sheet was 100×50×0.15 mm | 1. Stricture rate: 3/8 (37.5%) | None |
1. Superficial esophageal cancer | 2. The sheet was grasped with endoscopic forceps, wrapped around endoscope and anchored to anal end of mucosal defect and then deployed to cover entire esophageal circumference | 2. Time to stricture occurrence (day): mean±SD, 28±7 | ||||||||
2. Expected mucosal defect post-ESD at least two thirds of esophageal circumference | 3. No. of required EBD sessions: mean±SD, 0.8±1.2 | |||||||||
3. The same was repeated at oral end of mucosal defect | ||||||||||
Exclusion | ||||||||||
1. Systemic complications | 4. Fibrin glue was sprayed over the entire length of PGA sheet | |||||||||
2. Anaphylaxis to components of fibrin glue or drugs made of bovine lung | ||||||||||
3. Treatment with procoagulants, antifibrinolytic agents or aprotinin | 5. Application time of PGA sheet (min): mean±SD, 12.8±5.5 | |||||||||
4. Steroid use | ||||||||||
Isomoto et al. (2011) [14] | Japan | Prospective study | Inclusion | EBD | 3 | Day 3 (post-ESD), followed by twice weekly sessions for 8 weeks | EBD using a CRE balloon | No. of EBD session | 1. Stricture rate: 3/3 (100%) | None |
1. Superficial esophageal SCC treated by ESD | 1. First subject, 30 | 2. No. of EBD sessions: mean (range), 32.7 (20-48) | ||||||||
2. Mucosal defect involving full esophageal circumference | 2. Second subject, 20 | |||||||||
3. Third subject, 48 | ||||||||||
Oral steroids (prednisolone) | 4 | Day 3 (post-ESD), tapered gradually over next 8 weeks | Prednisolone started at 30 mg/day (orally administered) on day 3 (post-ESD), and then tapered gradually (daily 30, 30, 25, 25, 20, 15, 10, 5 mg for 7 days each) and then discontinued 8 weeks later | Total dose: 1,120 mg, distributed over 8 weeks in a tapered fashion | 1. Stricture rate: 2/4 (50%) | None | ||||
2. No. of EBD sessions: mean (range), 3.25 (0-11) | ||||||||||
Uno et al. (2012) [15] | Japan | Prospective study | Inclusion | EBD | 16 | Few days post-ESD (first session), followed by twice a week for 4 weeks | 1. EBD using a CRE balloon dilator | Total of 8 scheduled EBD sessions over 4 weeks post-ESD | 1. Stricture rate: 11/16 (68.8%) | Perforation: secondary to additional EBD session, 1/16 (6.25%), 1/98 additional EBD session (1.02%), asymptomatic patient successfully managed conservatively |
1. Superficial esophageal SCC treated by ESD | 2. Each treatment session consisted of 2 or 3 progressively larger diameters, with the dilation diameters increasing incrementally by not >3 mm | 2. No. of additional EBD sessions: median (IQR) | ||||||||
2. Mucosal defect involving more than three quarters of esophageal circumference | 1) At 8 weeks: 3 (0–3) | |||||||||
2) At 48 weeks: 4 (0–6.5) | ||||||||||
Exclusion | 3. Duration of EBD sessions required to resolve stricture (day): median (range), 58 (28-238) | |||||||||
1. History of GI surgery or EMR/ESD for upper GI malignancy | ||||||||||
2. History of chemoradiation therapy or other treatment for esophageal cancer | 4. Duration of ulcer healing (day): median (range), 52 (38-59) | |||||||||
3. Serious systemic disease | 5. Dysphagia score: median (range) | |||||||||
4. Subject with circumferential lesion whose longitudinal lengths were more than 50 mm | 1) At 16 weeks: 5 (1.5–6.0) | |||||||||
5. Use of medications known to influence esophageal motor function | 2) At 24 weeks: 3 (0–3.5) | |||||||||
6. Current steroid hormone or anti-coagulant use | 3) At 48 weeks: 0 (0–1.5) | |||||||||
EBD+Tranilast | 15 | 1. Few days post-ESD (first session), followed by twice a week for 4 weeks | 1. EBD using a CRE balloon dilator | 1. Total of 8 scheduled EBD sessions over 4 weeks post-ESD | 1. Stricture rate: 5/15 (33.3%) | None | ||||
2. Each treatment session consisted of 2 or 3 progressively larger diameters, with the dilation diameters increasing incrementally by not >3 mm | 2. Total of 16,800 mg of tranilast over 8 weeks | 2. No. of additional EBD sessions: median (IQR) | ||||||||
2. Tranilast few days post-ESD (first dose), continued for 8 weeks | 1) At 8 weeks: 0 (0–1.75) | |||||||||
3. Tranilast was administered orally, 300 mg per day in 3 divided doses with meals | 2) At 48 weeks: 0 (0–1.75) | |||||||||
3. Duration of EBD sessions required to resolve stricture (day): median (range), 28 (28–38.3) | ||||||||||
4. Duration of ulcer healing (day): median (range), 48 (42-55) | ||||||||||
5. Dysphagia score: median (range) | ||||||||||
1) At 16 weeks: 0 (0–3.0) | ||||||||||
2) At 24 weeks: 0 (0–0) | ||||||||||
3) At 48 weeks: 0 (0–0) | ||||||||||
Yamaguchi et al. (2011) [16] | Japan | Retrospective study | Inclusion | EBD | 1. Total: 22 | Day 3 (post-ESD), followed by twice weekly sessions for 8 weeks | EBD using a CRE balloon dilator, designed to deliver 3 distinct pressure controlled diameters (15, 16.5, 18 mm) at 3 separate pressures | Total of 16 scheduled EBD sessions over 8 weeks post-ESD | 1. Stricture rate at 3 months | Pneumomediastinum: 1/22 (4.5%), successfully managed conservatively |
1. Superficial esophageal SCC treated by ESD | 2. Subjects with semicircular ESD: 19 | 1) Composite: 7/21 (31.8%) | ||||||||
2. Mucosal defect involving more than three quarters of esophageal circumference (semicircular) or full esophageal circumference (circular) | 3. Subjects with circular ESD: 3 | 2) Semicircular ESD group: 4/19 (21.1%) | ||||||||
3) Circular ESD group: 3/3 (100%) | ||||||||||
Exclusion | ||||||||||
1. Patients with lesions suspected to involve muscularis mucosa or deeper tissue | ||||||||||
2. No. of total (planned+additional) EBD sessions: mean (range) | ||||||||||
1) Composite: 15.6 (0–48) | ||||||||||
2) Semicircular ESD group:12.9 (0–34) | ||||||||||
3) Circular ESD group: 32.7 (20–48) | ||||||||||
3. No. of additional EBD sessions: mean (range) | ||||||||||
1) Composite: 6.8 (0–32) | ||||||||||
2) Semicircular ESD group: 3.1 (0–18) | ||||||||||
3) Circular ESD group: 16.7 (4–32) | ||||||||||
Oral steroids (prednisolone) | 1. Total: 19 | Day 3 (post-ESD), tapered gradually over next 8 weeks, except for one subject (12 weeks) | Prednisolone started at 30 mg/day (orally administered) on day 3 (post-ESD), and then tapered gradually (daily 30, 30, 25, 25, 20, 15, 10, 5 mg for 7 days each) and then discontinued 8 weeks later, except for one (12 weeks) | Total dose: 1,120 mg, distributed over 8 weeks in a tapered fashion for all subjects except one | 1. Stricture rate at 3 months | None | ||||
2. Subjects with semicircular ESD: 16 | 1) Composite: 1/19 (5.3%) | |||||||||
3. Subjects with circular ESD: 3 | 2) Semicircular ESD group: 1/16 (6.3%) | |||||||||
3) Circular ESD group: 0/3 (0%) | ||||||||||
2. No. of EBD sessions: mean (range) | ||||||||||
1) Composite: 1.7 (0–7) | ||||||||||
2) Semicircular ESD group: 2.1 (0–7) | ||||||||||
3) Circular ESD group: 0.7 (0–2) | ||||||||||
Wen et al. (2014) [17] | China | Prospective, randomized controlled study | Inclusion | Covered esophageal metal stent placement (composed of high elastic stainless steel and is covered with high intensity medical silicone membrane) | 11 | Day 0 (post-ESD) | 1. Stent length (25 to 180 mm) and diameter (15 to 18 mm) was selected based on size of mucosal defect | One stent per subject | 1. Stricture rate: 2/11 (18.2%) | 1. Chest pain: self resolved, no medication or intervention required |
1. Superficial esophageal SCC treated ESD | 2. Stent was placed via guidewire and endoscope | 2. No. of required bougie dilation: mean (range), 0.45 (0–3) | 2. GI bleed at stent removal: self resolved, no intervention required | |||||||
2. Mucosal defect more than three quarter of circumference | 3. Second endoscopy was done to ensure stent opening is >2 cm from the upper and lower peel surface | 3. At 12 weeks post-ESD: complete epithelialization of the mucosal defect was noted for all subjects | ||||||||
3. No lymph node metastases on CT scanning | 3. Stent was removed 8 weeks post-ESD | |||||||||
4. No organ failure | ||||||||||
Exclusion | ||||||||||
1. Presence of GI tumor | ||||||||||
2. Esophageal cancer after radiotherapy | ||||||||||
3. Multiple esophageal cancers | ||||||||||
4. Diabetes | ||||||||||
5. Associated severe condition: renal/cardiac or respiratory failure | ||||||||||
6. Brain dysfunction | ||||||||||
No stent placed | 11 | NA | NA | NA | 1. Stricture rate: 8/11 (72.7%) | NA | ||||
2. No. of required bougie dilation: mean (range), 3.9 (0–17) | ||||||||||
Lee et al. (2013) [18] | Korea | Case report | Inclusion | Endoscopic Intralesional steroid (triamcinolone acetonide) injection, diluted with saline to make 20 mg/mL solution | 1 | Day 0 (post-ESD) | 1. 0.5 mL dose injected at eight sites across ulcer base | Total dose: 80 mg | Post-ESD scar noted, no stricture, no dysphagia, no EBD requirement | None |
1. Superficial esophageal SCC treated by ESD | 2. Injected into deep submucosa and the superficial proper muscle layer of ulcer base | |||||||||
2. Mucosal defect involving near full esophageal circumference |
SCC, squamous cell cancer; ESD, endoscopic submucosal dissection; EBD, endoscopic balloon dilation; NA, not available; TA, triamcinolone acetonide; CT, computed tomography; HbA1c, glycated hemoglobin; DM, diabetes mellitus; MCFP, mucosal defect covered with fibrin glue and polyglycolic acid; PGA, polyglycolic acid; CRE, controlled radial expansion; GI, gastrointestinal; EMR, endoscopic mucosal resection; IQR, interquartile range.
Study | Country | Study type | Intervention to prevent esophageal stricture development | ESD | Size of mucosal defect |
---|---|---|---|---|---|
Hashimoto et al. (2011) [7] | Japan | Prospective study | ETI, 10 mg/mL solution | 1. Resection size (mm): mean (range), 54.9 (28-67) | More than three quarter but less than whole circumference |
2. ESD procedure time (min): mean (range), 150.5 (90-290) | |||||
Historical control group (no intervention) | 1. Resection size (mm): mean (range), 62.4 (40-100) | ||||
2. ESD procedure time (min): mean (range), 186.2 (78-240) | |||||
Hanaoka et al. (2012) [8] | Japan | Prospective study | Endoscopic intralesional steroid (triamcinolone acetonide) injection, diluted with saline to make 5 mg/mL solution | 1. Mucosal incision and submucosal dissection were performed with a flush knife/hook knife/mucosectomy and 0.4% hyaluronic acid solution used for submucosa injection | Length of mucosal defect (mm): mean±SD, 58±11 |
2. Minor bleeding was stopped using endoscopy knives in a forced coagulation mode | |||||
3. Major bleeding was coagulated with hemostatic forceps, using the soft coagulation mode at 80 W | |||||
Historical control group (no intervention) | NA | Length of mucosal defect (mm): mean±SD, 52±18 | |||
Mori et al. (2013) [9] | Japan | Prospective, randomized study | Local steroid injection and balloon dilation | 1. Resection size (mm): mean (range), 54.2 (28-80) | Circumference ratio of lesion (%): mean±SD, 84±15 |
2. ESD procedure time (min): mean (range), 195.7 (65-300) | |||||
Steroid gel application and balloon dilation | 1. Resection size (mm): mean (range), 57.1 (40-80) | Circumference ratio of lesion (%): mean±SD, 82±14 | |||
2. ESD procedure time (min): mean (range), 179.2 (90-300) | |||||
Takahashi et al. (2015) [10] | Japan | Prospective randomized controlled, open label, single center study | Endoscopic steroid injection therapy | 1. Size of resected specimen (mm): mean±SD (range), 68±14 (43-97) | Circumferential extent |
1. >2/3 to <3/4: 4 subjects | |||||
2. Operation time (min): mean±SD (range), 89.6±37.5 (36-176) | 2. >3/4 to <1: 7 subjects | ||||
3. =1: 5 subjects | |||||
None | 1. Size of resected specimen (mm): mean±SD (range), 62±17 (39-101) | Circumferential extent | |||
1. >2/3 to <3/4: 6 subjects | |||||
2. Operation time (min): mean±SD (range), 88.3±44.5 (44-235) | 2. >3/4 to <1: 5 subjects | ||||
3. =1: 5 subjects | |||||
Ohki et al. (2012) [11] | Japan | Prospective open label, single arm, single center study | Transplantation of autologous cell sheets to ulcer surfaces via an endoscope | 1. ESD using a hook knife | Circumference |
2. Iodine staining to identify the site | 1. Half: 1 subject | ||||
3. Glycerol and carmine solution was injected to separate the mucosal layer | 2. Two third: 4 subjects | ||||
3. Three fourth: 3 subjects | |||||
4. Almost whole: 1 subject | |||||
Iizuka et al. (2015) [12] | Japan | Prospective, single center study | MCFP technique | 1. An EG450-RD5 endoscope and a dual knife for ESD | The whole esophageal circumference was divided into 12 equal subparts to measure the size of defect |
2. Glycerol with small amounts of indigo carmine and epinephrine for injection | 1. 7/12: 4 subjects | ||||
2. 8/12: 5 subjects | |||||
3. ICC200 high frequency generator for radiofrequency ablation | 3. 9/12: 4 subjects | ||||
4. 10/12: 1 subjects | |||||
5. 11/12: 1 subjects | |||||
Sakaguchi et al. (2015) [13] | Japan | Prospective pilot study, single arm, single center | PGA sheet deployment with fibrin glue | 1. ESD using dual knife | More than three quarter of esophageal circumference |
2. Chromoendoscopy using iodine staining to identify the site | |||||
3. Hyaluronic acid solution was injected submucosally | |||||
4. Size of resected specimen (mm): mean±SD, 53.8±8.8 | |||||
5. Total dissection time (min): mean±SD, 120±28.8 | |||||
Isomoto et al. (2011) [14] | Japan | Prospective study | EBD | 1. Resection size (mm): mean (range), 69 (43–94) | Full esophageal circumference |
2. Mucosal incision with flush knife under the Endo cut 1 mode, submucosal dissection with flush knife under the forced coagulation mode. Hemostatic forceps un soft coagulation mode used to stop achieve hemostasis. | |||||
Oral steroids (prednisolone) | 1. Resection size (mm): mean (range), 76.5 (70–81) | ||||
2. Mucosal incision with flush knife under the Endo cut 1 mode, submucosal dissection with flush knife under the forced coagulation mode. Hemostatic forceps in soft coagulation mode was used to achieve hemostasis. | |||||
Uno et al. (2012) [15] | Japan | Prospective study | EBD | Procedure time (min): mean±SD, 131.6±44.4 | Circumferential extent |
1. ≥3/4: 14 subjects | |||||
2. =1: 2 subjects | |||||
EBD+Tranilast | Procedure time (min): mean±SD, 122.5±37.7 | Circumferential extent | |||
1. ≥3/4: 12 subjects | |||||
2. =1: 3 subjects | |||||
Yamaguchi et al. (2011) [16] | Japan | Retrospective study | EBD | 1. Tumor size (mm): mean (range), 30.4 (9–67) | Circumferential extent |
2. Operation time (min): mean (range), 95.5 (47–168) | 1. ≥3/4: 19 subjects | ||||
2. =1: 3 subjects | |||||
Oral steroids (prednisolone) | 1. Tumor size (mm): mean (range), 33.4 (11–84) | Circumferential extent | |||
2. Operation time (min): mean (range), 93.9 (40–260) | 1. ≥3/4: 16 subjects | ||||
2. =1: 3 subjects | |||||
Wen et al. (2014) [17] | China | Prospective, randomized controlled study | Covered esophageal metal stent placement (composed of high elastic stainless steel and is covered with high intensity medical silicone membrane) | ESD procedure time (min): mean (range), 310.2±106.7 | Circumferential extent |
1. ≥3/4: 5 subjects | |||||
2. ≥4/5: 2 subjects | |||||
3. =1: 4 subjects | |||||
No stent placed | ESD procedure time (min): mean (range), 265.1±106.0 | Circumferential extent | |||
1. ≥3/4: 6 subjects | |||||
2. ≥4/5: 3 subjects | |||||
3. =1: 2 subjects | |||||
Lee et al. (2013) [18] | Korea | Case report | Endoscopic Intralesional steroid (triamcinolone acetonide) injection, diluted with saline to make 20 mg/mL solution | 1. Mucosal incision and dissection were performed with a hook knife and an IT knife | Near full esophageal circumference |
2. 80 mL of normal saline mixed with epinephrine was injected to lift the mucosa including the tumor | |||||
3. Bleeding controlled with hemostatic forceps | |||||
4. Total time: 55 minutes |
Study | Country | Study type | Intervention to prevent esophageal stricture development | Monitoring and F/U | Stricture criteria |
---|---|---|---|---|---|
Hashimoto et al. (2011) [7] | Japan | Prospective study | ETI, 10 mg/mL solution | Esophagoscopy routinely at 1 week, 1, 6 months, and 1 year post-ETI, clinical F/U for dysphagia | Standard endoscope GIF-Q240 cannot pass through the ESD scar |
Historical control group (no intervention) | NA | ||||
Hanaoka et al. (2012) [8] | Japan | Prospective study | Endoscopic Intralesional steroid (triamcinolone acetonide) injection, diluted with saline to make 5 mg/mL solution | Endoscopy (EGD) routinely at 2 months post-ESD or earlier if dysphagia was reported | Dysphagia to solids (dysphagia score 2) or an inability to pass a >9.2 mm diameter endoscope |
Historical control group (no intervention) | NA | ||||
Mori et al. (2013) [9] | Japan | Prospective, randomized study | Local steroid injection and balloon dilation | Gastrograffin esophagograms on day 5, 8, 12, 15, 20, 30, 60 and clinical F/U for dysphagia | Inability to pass a 10 mm diameter endoscope through ESD scar in a patient complaining of dysphagia and requiring EBD |
Steroid gel application and balloon dilation | |||||
Takahashi et al. (2015) [10] | Japan | Prospective randomized controlled, open label, single center study | Endoscopic steroid injection therapy | 1. EGD, 6 days post-injection therapy | Esophageal diameter <11 mm or inability to achieve or maintain a diameter of 14 mm despite dilatation every 2–4 weeks |
2. Barium contrast esophagography in patients complaining of dysphagia or 4 weeks after the last EGD if patients were asymptomatic | |||||
None | Barium contrast esophagogra-phy in patients complaining of dysphagia or 4 weeks after the last EGD if patients were asymptomatic | ||||
Ohki et al. (2012) [11] | Japan | Prospective open label, single arm, single center study | Transplantation of autologous cell sheets to ulcer surfaces via an endoscope | Weekly endoscopy until epithelialization was complete | NA |
Iizuka et al. (2015) [12] | Japan | Prospective, single center study | MCFP technique | EGD at 1,2,4, and 6 weeks after ESD F/U (day): median (range), 352 (60-535) | Inability to pass H260 endoscope through the ESD scar |
Sakaguchi et al. (2015) [13] | Japan | Prospective pilot study, single arm, single center | PGA sheet deployment with fibrin glue | Scheduled endoscopy on day 7 and 28 or if clinically indicated based on symptom | Inability to pass 9.8 mm diameter endoscope (GIF Q240 or GIF H260) through the ESD scar |
Isomoto et al. (2011) [14] | Japan | Prospective study | EBD | 1. F/U endoscopy with iodine staining and biopsy if abnormal mucosa noted at 3, 6, and 12 months post-ESD | NA |
2. CT scan of cervix, thorax and abdomen at 3, 6 and 12 months post-ESD | |||||
3. Clinical F/U for dysphagia | |||||
Oral steroids (prednisolone) | |||||
Uno et al. (2012) [15] | Japan | Prospective study | EBD | 1. Scheduled consultations and F/U examinations by EGD (earlier if clinically warranted) for 48 weeks | Inability to pass 10.8 mm standard endoscope through the suspected esophageal region |
3. F/U period: mean±SD, 28.4±11.9 months | |||||
EBD+Tranilast | 1. Scheduled consultations and F/U examinations by EGD (earlier if clinically warranted) for 48 weeks | ||||
2. For tranilast- physical examination and blood work up including complete blood count, hepatic and kidney function tests weekly for first 4 weeks, and thereafter at 8, 16,24, and 48 weeks post-ESD | |||||
3. F/U period: mean±SD, 24.3±7.4 months | |||||
Yamaguchi et al. (2011) [16] | Japan | Retrospective study | EBD | 1. F/U endoscopy with iodine staining and biopsy if abnormal mucosa noted at 1, 3, 6, and 12 months post-ESD | NA |
2. CT scan of neck, chest and abdomen annually, post-ESD | |||||
3. Clinical F/U for dysphagia | |||||
Oral steroids (prednisolone) | |||||
Wen et al. (2014) [17] | China | Prospective, randomized controlled study | Covered esophageal metal stent placement (composed of high elastic stainless steel and is covered with high intensity medical silicone membrane) | 1. Routine F/U gastroscopy was done, 4 weeks post-ESD | <9.8 mm opening that did not permit the passage of GIF H260 endoscope through it |
2. Routine F/U endoscopy was done at 12 weeks post-ESD or when patient exhibited dysphagia symptoms to solid food | |||||
No stent placed | Routine F/U endoscopy was done at 12 weeks post-ESD or when patient exhibited dysphagia symptoms to solid food | ||||
Lee et al. (2013) [18] | Korea | Case report | Endoscopic intralesional steroid (triamcinolone acetonide) injection, diluted with saline to make 20 mg/mL solution | Esophagography at 2 and 4 weeks, EGD at 4 months post-ESD, clinical F/U for dysphagia | NA |
Study | Country | Study type | Inclusion/exclusion criteria | Intervention to prevent esophaged stricture development | No. of subjects | Timing of intervention | Technique | Dose | Outcome | Complication secondary to intervention or dilation session |
---|---|---|---|---|---|---|---|---|---|---|
Hashimoto et al. (2011) [7] | Japan | Prospective study | Inclusion | Endoscopic triamcinolone injection, 10 mg/mL solution | 21 | Day 3,7 and 10 (post-ESD) | 1. A 25 G, 4 mm needle tos used | Total dose per session (varied with ulcer size): range, 18-62 mg | 1. Stricture rate: 4/21 (19%) | None |
1. Superficial esophageal SCC treated by ESD | 2.1 mL syringe was used to inject manually | 2. No. of required EBD: mean (range), 1.7 (0-15) | ||||||||
2. Mucosal defect involving three fourth of esophageal circumference | 3. Steroid tos injected in aliquots of 0.2 mL, 1 cm apart in semicircumferential fashion | |||||||||
4. No. of injections per session (varied with ulcer size): range, 9-31 | ||||||||||
Historical control group (no intervention) | 20 | NA | NA | NA | 1. Stricture rate: 15/20 (75%) | NA | ||||
2. No. of required EBD: mean (range), 6.6 (0-20) | ||||||||||
Hanaoka et al. (2012) [8] | Japan | Prospective study | Inclusion | Endoscopic Intralesional steroid (TA) injection, diluted with saline to make 5 mg/mL solution | 30 | Day 0 (post-ESD) | 1. A25G needle was used | 100 mg (irrespective of ulcer bed size) | 1. Stricture rate: 3/30 (10%) | Complication rate: 2/30 (7%) |
1. Esophageal SCC treated by ESD | 2. Injected evenly into the residual submucosal tissue of ulcer bed in 0.5-1.0 ml increments (20-40 punctures) | 2. No. of EBD session: median (range), 0 (0-2) | 1. Deep submucosal tear without perforation (during stricture evaluation 2 months post-ESD): 1/2 managed conservatively (fasting) | |||||||
2. Mucosal defect more than three quarter but less than whole circumference | 3. The initial injections were given at the margins of the ulcer and these were followed by linear injections given from the distal side to proximal side of the ulcer margin | |||||||||
3. No lymph node metastases on CT scanning | 4. If muscle layer tos partially exposed post-ESD, steroid injection tos not performed in that area | 2. Esophageal hemorrhage: 1/2 tarry stools (8 days post-ESD)-required endoscopic hemostasis | ||||||||
4. No organ failure | ||||||||||
Exclusion | ||||||||||
1. Active synchronous cancer | ||||||||||
2. Prior radiation therapy for esophageal cancer | ||||||||||
3. Multiple esophageal cancers | ||||||||||
4. Liver cirrhosis | ||||||||||
5. Poorly controlled DM | ||||||||||
6. Mucosal defect involving whole esophageal circumference | ||||||||||
Inclusion | Historical control group (no intervention) | 29 | NA | NA | NA | 1. Stricture rate: 19/29(66%) | NA | |||
1. Superficial esophageal SCC treated byESD | 2. No. of EBD session: median (range), 2 (0-15) | |||||||||
2. Mucosal defect more than three quarter but less than whole circumference | ||||||||||
Exclusion | ||||||||||
1. Active synchronous cancer | ||||||||||
2. Prior radiation therapy for esophageal cancer | ||||||||||
3. Multiple esophageal cancers | ||||||||||
4. Liver cirrhosis | ||||||||||
5. Poorly controlled DM | ||||||||||
Mori et al. (2013) [9] | Japan | Prospective, randomized study | Inclusion | Local steroid injection and balloon dilation | 23 (2 subjects were excluded because of bleeding, see complication section) | Day 5,8,12, and 15 | TA injection (each of 0.2 mL/2 mg) into ulcer floor at 8 mm intervals with extra care to avoid injection into muscularis propria, followed by 5 minutes session of EBD | Range, 62–88 mg of TA | 1. No. of EBD sessions after day 20: mean (range), 4.27 (0-12) | 1. No. of subjects with oaring bleeding before day 15: mean (range), 0.46 (0-2); both of these subjects were on oral anticoagulants and required endoscopic hemostasis |
1. Early esophageal cancer | 2. Procedure time (min): mean (range), 7.33 (5-11) | |||||||||
2. Mucosal defect involving two third to entire circumference | 3. Stricture rate (%): mean±SD | |||||||||
1) Day 5: 78±22 | ||||||||||
2) Day 8: 81±21 | ||||||||||
3) Day 12: 76±24 | ||||||||||
4) Day 15: 82±19 | ||||||||||
5) Day 20: 83±19 | ||||||||||
6) Day 30: 83±16 | ||||||||||
7) Day 60: 81±22 | ||||||||||
Steroid gel application and balloon dilation | 20 | Day 5,8,12, and 15 | 10 mL of TA gel mixed with 7.5 mL of endolubri jelly, applied from distal to proximal end of ulcer with spraying tube via endoscope; followed by 5 minutes session of EBD | 100 mg of TA | 1. No. of EBD sessions after day 20: mean (range), 1.6 (0-5) | None | ||||
2. Procedure time (min): mean (range), 6.87 (6-8) | ||||||||||
3. Stricture rate (%): mean±SD | ||||||||||
1) Day 5: 80±17 | ||||||||||
2) Day 8: 79±18 | ||||||||||
3) Day 12: 82±15 | ||||||||||
4) Day 15: 83±15 | ||||||||||
5) Day 20: 83±13 | ||||||||||
6) Day 30: 85±14 | ||||||||||
7) Day 60: 81±21 | ||||||||||
Takahashi et al. (2015) [10] | Japan | Prospective randomized controlled, open label, single center study | Inclusion | Endoscopic steroid injection therapy | 16 | Day 0 (post-ESD) | 1. TA diluted with 0.9% NaCl to final concentration of 10 mg/mL | NA | 1. Stricture rate: 10/16 (62.5%) | Perforation: 1/97 (1.0%) |
1. Early esophageal SCC | 2. 0.5 mL aliquots injected at ulcer base using 25 G, 3 mm needle | 2. No. of required dilation sessions: mean±SD (range), 6.1±6.2 (0–17) | ||||||||
2. Expected mucosal defect more than three quarter of esophageal circumference | 3. Starting at distal edge, repeated evenly at points 10 mm apart, upto proximal edge | 3. Duration of dilation therapy (mo): mean±SD (range), 3.5±4.0 (0-13) | ||||||||
4. Special precautions to avoid injecting into muscularis propria | 4. Minimum diameter of strictured region (mm): mean±SD (range), 11.0±4.6 (5.4–21.8) | |||||||||
Exclusion | ||||||||||
1. Subjects who received additional adjuvant treatment- surgery or chemoradiation | ||||||||||
2. Subjects who were not regularly or adequately followed up | ||||||||||
None | 16 | NA | NA | NA | 1. Stricture rate: 14/16 (87.5%) | Perforation: 1/200 (0.5%) | ||||
2. No. of required dilation sessions: mean±SD (range), 12.5±10.1 (0–140) | ||||||||||
3. Duration of dilation therapy (mo): mean±SD (range), 6.1±5.0 (0–20) | ||||||||||
4. Minimum diameter of stricture (mm): mean±SD (range), 7.1±2.9 (5.1–12.8) | ||||||||||
Ohki et al. (2012) [11] | Japan | Prospective open label, single arm, single center study | Inclusion | Transplantation of autologous cell sheets to ulcer surfaces via an endoscope | 9 | Day 0 (post-ESD) | The polyvinylidene difluoride support membrane with an attached autologous oral mucosal epithelial cell sheet, grasped by endoscopic forceps and placed over the ulcer site via EMR tube | No. of transplanted cell sheets: range, 2-8; each sheet being 23.4 mm in diameter | Stricture rate: 1/9 (11.1%; the subject had full circumferential mucosal defect extending upto gastroesophageal junction and required EBD 21 times) | High grade fever: 4/9 subjects, no intervention required |
1. Esophageal cancer | ||||||||||
2. Expected mucosal defect post-ESD at least two thirds of esophageal circumference | ||||||||||
Exclusion | ||||||||||
1. DM (HbA1c ≥10) | ||||||||||
2. Corticosteroid use | ||||||||||
3. Undergoing treatment for oral cancer | ||||||||||
4. Receiving radiotherapy for esophageal cancer | ||||||||||
Iizuka et al. (2015) [12] | Japan | Prospective, single center study | Inclusion | MCFP technique | 15 (2 subjects underwent surgical resection at day 20 and 30 post-ESD due to extent of disease) | Day 0 (post-ESD) | 1. Spraying fibrinogen solution at mucosal defect | Mean no. of PGA sheets used: 10 (each sheet was 15×7 mm) | 1. Stricture rate at 6 weeks post-ESD: 1/13 (7.7%) | Bleeding: 1/15- post-ESD, conservatively managed |
1. Superficial esophageal SCC treated by ESD | 2. PGA sheet patches were placed without overlapping | 2. No. of required EBD: 5 times for one patient | ||||||||
2. Mucosal defect involving more than half but less than whole esophageal circumference | 3. Fibrinogen and thrombin solutions were sprayed over the sheets | 3. Dysphagia: 3/13, one had stricture, two had no stricture | ||||||||
Exclusion | ||||||||||
1. History of esophagectomy | ||||||||||
2. History of radiation therapy | ||||||||||
3. A lesion near a scar left after previous endoscopic resection | ||||||||||
4. A lesion suspected preoperatively to be m3 or sml stage | ||||||||||
5. Uncontrolled DM | ||||||||||
6. Current steroid hormone use | ||||||||||
Sakaguchi et al. (2015) [13] | Japan | Prospective pilot study, single arm, single center | Inclusion | PGA sheet deployment with fibrin glue | 8 | Day 0 (post-ESD) | 1. The PGA sheet was deployed using modified version of clip and pull method | Each PGA sheet was 100×50×0.15 mm | 1. Stricture rate: 3/8 (37.5%) | None |
1. Superficial esophageal cancer | 2. The sheet was grasped with endoscopic forceps, wrapped around endoscope and anchored to anal end of mucosal defect and then deployed to cover entire esophageal circumference | 2. Time to stricture occurrence (day): mean±SD, 28±7 | ||||||||
2. Expected mucosal defect post-ESD at least two thirds of esophageal circumference | 3. No. of required EBD sessions: mean±SD, 0.8±1.2 | |||||||||
3. The same was repeated at oral end of mucosal defect | ||||||||||
Exclusion | ||||||||||
1. Systemic complications | 4. Fibrin glue was sprayed over the entire length of PGA sheet | |||||||||
2. Anaphylaxis to components of fibrin glue or drugs made of bovine lung | ||||||||||
3. Treatment with procoagulants, antifibrinolytic agents or aprotinin | 5. Application time of PGA sheet (min): mean±SD, 12.8±5.5 | |||||||||
4. Steroid use | ||||||||||
Isomoto et al. (2011) [14] | Japan | Prospective study | Inclusion | EBD | 3 | Day 3 (post-ESD), followed by twice weekly sessions for 8 weeks | EBD using a CRE balloon | No. of EBD session | 1. Stricture rate: 3/3 (100%) | None |
1. Superficial esophageal SCC treated by ESD | 1. First subject, 30 | 2. No. of EBD sessions: mean (range), 32.7 (20-48) | ||||||||
2. Mucosal defect involving full esophageal circumference | 2. Second subject, 20 | |||||||||
3. Third subject, 48 | ||||||||||
Oral steroids (prednisolone) | 4 | Day 3 (post-ESD), tapered gradually over next 8 weeks | Prednisolone started at 30 mg/day (orally administered) on day 3 (post-ESD), and then tapered gradually (daily 30, 30, 25, 25, 20, 15, 10, 5 mg for 7 days each) and then discontinued 8 weeks later | Total dose: 1,120 mg, distributed over 8 weeks in a tapered fashion | 1. Stricture rate: 2/4 (50%) | None | ||||
2. No. of EBD sessions: mean (range), 3.25 (0-11) | ||||||||||
Uno et al. (2012) [15] | Japan | Prospective study | Inclusion | EBD | 16 | Few days post-ESD (first session), followed by twice a week for 4 weeks | 1. EBD using a CRE balloon dilator | Total of 8 scheduled EBD sessions over 4 weeks post-ESD | 1. Stricture rate: 11/16 (68.8%) | Perforation: secondary to additional EBD session, 1/16 (6.25%), 1/98 additional EBD session (1.02%), asymptomatic patient successfully managed conservatively |
1. Superficial esophageal SCC treated by ESD | 2. Each treatment session consisted of 2 or 3 progressively larger diameters, with the dilation diameters increasing incrementally by not >3 mm | 2. No. of additional EBD sessions: median (IQR) | ||||||||
2. Mucosal defect involving more than three quarters of esophageal circumference | 1) At 8 weeks: 3 (0–3) | |||||||||
2) At 48 weeks: 4 (0–6.5) | ||||||||||
Exclusion | 3. Duration of EBD sessions required to resolve stricture (day): median (range), 58 (28-238) | |||||||||
1. History of GI surgery or EMR/ESD for upper GI malignancy | ||||||||||
2. History of chemoradiation therapy or other treatment for esophageal cancer | 4. Duration of ulcer healing (day): median (range), 52 (38-59) | |||||||||
3. Serious systemic disease | 5. Dysphagia score: median (range) | |||||||||
4. Subject with circumferential lesion whose longitudinal lengths were more than 50 mm | 1) At 16 weeks: 5 (1.5–6.0) | |||||||||
5. Use of medications known to influence esophageal motor function | 2) At 24 weeks: 3 (0–3.5) | |||||||||
6. Current steroid hormone or anti-coagulant use | 3) At 48 weeks: 0 (0–1.5) | |||||||||
EBD+Tranilast | 15 | 1. Few days post-ESD (first session), followed by twice a week for 4 weeks | 1. EBD using a CRE balloon dilator | 1. Total of 8 scheduled EBD sessions over 4 weeks post-ESD | 1. Stricture rate: 5/15 (33.3%) | None | ||||
2. Each treatment session consisted of 2 or 3 progressively larger diameters, with the dilation diameters increasing incrementally by not >3 mm | 2. Total of 16,800 mg of tranilast over 8 weeks | 2. No. of additional EBD sessions: median (IQR) | ||||||||
2. Tranilast few days post-ESD (first dose), continued for 8 weeks | 1) At 8 weeks: 0 (0–1.75) | |||||||||
3. Tranilast was administered orally, 300 mg per day in 3 divided doses with meals | 2) At 48 weeks: 0 (0–1.75) | |||||||||
3. Duration of EBD sessions required to resolve stricture (day): median (range), 28 (28–38.3) | ||||||||||
4. Duration of ulcer healing (day): median (range), 48 (42-55) | ||||||||||
5. Dysphagia score: median (range) | ||||||||||
1) At 16 weeks: 0 (0–3.0) | ||||||||||
2) At 24 weeks: 0 (0–0) | ||||||||||
3) At 48 weeks: 0 (0–0) | ||||||||||
Yamaguchi et al. (2011) [16] | Japan | Retrospective study | Inclusion | EBD | 1. Total: 22 | Day 3 (post-ESD), followed by twice weekly sessions for 8 weeks | EBD using a CRE balloon dilator, designed to deliver 3 distinct pressure controlled diameters (15, 16.5, 18 mm) at 3 separate pressures | Total of 16 scheduled EBD sessions over 8 weeks post-ESD | 1. Stricture rate at 3 months | Pneumomediastinum: 1/22 (4.5%), successfully managed conservatively |
1. Superficial esophageal SCC treated by ESD | 2. Subjects with semicircular ESD: 19 | 1) Composite: 7/21 (31.8%) | ||||||||
2. Mucosal defect involving more than three quarters of esophageal circumference (semicircular) or full esophageal circumference (circular) | 3. Subjects with circular ESD: 3 | 2) Semicircular ESD group: 4/19 (21.1%) | ||||||||
3) Circular ESD group: 3/3 (100%) | ||||||||||
Exclusion | ||||||||||
1. Patients with lesions suspected to involve muscularis mucosa or deeper tissue | ||||||||||
2. No. of total (planned+additional) EBD sessions: mean (range) | ||||||||||
1) Composite: 15.6 (0–48) | ||||||||||
2) Semicircular ESD group:12.9 (0–34) | ||||||||||
3) Circular ESD group: 32.7 (20–48) | ||||||||||
3. No. of additional EBD sessions: mean (range) | ||||||||||
1) Composite: 6.8 (0–32) | ||||||||||
2) Semicircular ESD group: 3.1 (0–18) | ||||||||||
3) Circular ESD group: 16.7 (4–32) | ||||||||||
Oral steroids (prednisolone) | 1. Total: 19 | Day 3 (post-ESD), tapered gradually over next 8 weeks, except for one subject (12 weeks) | Prednisolone started at 30 mg/day (orally administered) on day 3 (post-ESD), and then tapered gradually (daily 30, 30, 25, 25, 20, 15, 10, 5 mg for 7 days each) and then discontinued 8 weeks later, except for one (12 weeks) | Total dose: 1,120 mg, distributed over 8 weeks in a tapered fashion for all subjects except one | 1. Stricture rate at 3 months | None | ||||
2. Subjects with semicircular ESD: 16 | 1) Composite: 1/19 (5.3%) | |||||||||
3. Subjects with circular ESD: 3 | 2) Semicircular ESD group: 1/16 (6.3%) | |||||||||
3) Circular ESD group: 0/3 (0%) | ||||||||||
2. No. of EBD sessions: mean (range) | ||||||||||
1) Composite: 1.7 (0–7) | ||||||||||
2) Semicircular ESD group: 2.1 (0–7) | ||||||||||
3) Circular ESD group: 0.7 (0–2) | ||||||||||
Wen et al. (2014) [17] | China | Prospective, randomized controlled study | Inclusion | Covered esophageal metal stent placement (composed of high elastic stainless steel and is covered with high intensity medical silicone membrane) | 11 | Day 0 (post-ESD) | 1. Stent length (25 to 180 mm) and diameter (15 to 18 mm) was selected based on size of mucosal defect | One stent per subject | 1. Stricture rate: 2/11 (18.2%) | 1. Chest pain: self resolved, no medication or intervention required |
1. Superficial esophageal SCC treated ESD | 2. Stent was placed via guidewire and endoscope | 2. No. of required bougie dilation: mean (range), 0.45 (0–3) | 2. GI bleed at stent removal: self resolved, no intervention required | |||||||
2. Mucosal defect more than three quarter of circumference | 3. Second endoscopy was done to ensure stent opening is >2 cm from the upper and lower peel surface | 3. At 12 weeks post-ESD: complete epithelialization of the mucosal defect was noted for all subjects | ||||||||
3. No lymph node metastases on CT scanning | 3. Stent was removed 8 weeks post-ESD | |||||||||
4. No organ failure | ||||||||||
Exclusion | ||||||||||
1. Presence of GI tumor | ||||||||||
2. Esophageal cancer after radiotherapy | ||||||||||
3. Multiple esophageal cancers | ||||||||||
4. Diabetes | ||||||||||
5. Associated severe condition: renal/cardiac or respiratory failure | ||||||||||
6. Brain dysfunction | ||||||||||
No stent placed | 11 | NA | NA | NA | 1. Stricture rate: 8/11 (72.7%) | NA | ||||
2. No. of required bougie dilation: mean (range), 3.9 (0–17) | ||||||||||
Lee et al. (2013) [18] | Korea | Case report | Inclusion | Endoscopic Intralesional steroid (triamcinolone acetonide) injection, diluted with saline to make 20 mg/mL solution | 1 | Day 0 (post-ESD) | 1. 0.5 mL dose injected at eight sites across ulcer base | Total dose: 80 mg | Post-ESD scar noted, no stricture, no dysphagia, no EBD requirement | None |
1. Superficial esophageal SCC treated by ESD | 2. Injected into deep submucosa and the superficial proper muscle layer of ulcer base | |||||||||
2. Mucosal defect involving near full esophageal circumference |
Study | Country | Study type | Intervention to prevent esophageal stricture development | ESD | Size of mucosal defect |
---|---|---|---|---|---|
Hashimoto et al. (2011) [7] | Japan | Prospective study | ETI, 10 mg/mL solution | 1. Resection size (mm): mean (range), 54.9 (28-67) | More than three quarter but less than whole circumference |
2. ESD procedure time (min): mean (range), 150.5 (90-290) | |||||
Historical control group (no intervention) | 1. Resection size (mm): mean (range), 62.4 (40-100) | ||||
2. ESD procedure time (min): mean (range), 186.2 (78-240) | |||||
Hanaoka et al. (2012) [8] | Japan | Prospective study | Endoscopic intralesional steroid (triamcinolone acetonide) injection, diluted with saline to make 5 mg/mL solution | 1. Mucosal incision and submucosal dissection were performed with a flush knife/hook knife/mucosectomy and 0.4% hyaluronic acid solution used for submucosa injection | Length of mucosal defect (mm): mean±SD, 58±11 |
2. Minor bleeding was stopped using endoscopy knives in a forced coagulation mode | |||||
3. Major bleeding was coagulated with hemostatic forceps, using the soft coagulation mode at 80 W | |||||
Historical control group (no intervention) | NA | Length of mucosal defect (mm): mean±SD, 52±18 | |||
Mori et al. (2013) [9] | Japan | Prospective, randomized study | Local steroid injection and balloon dilation | 1. Resection size (mm): mean (range), 54.2 (28-80) | Circumference ratio of lesion (%): mean±SD, 84±15 |
2. ESD procedure time (min): mean (range), 195.7 (65-300) | |||||
Steroid gel application and balloon dilation | 1. Resection size (mm): mean (range), 57.1 (40-80) | Circumference ratio of lesion (%): mean±SD, 82±14 | |||
2. ESD procedure time (min): mean (range), 179.2 (90-300) | |||||
Takahashi et al. (2015) [10] | Japan | Prospective randomized controlled, open label, single center study | Endoscopic steroid injection therapy | 1. Size of resected specimen (mm): mean±SD (range), 68±14 (43-97) | Circumferential extent |
1. >2/3 to <3/4: 4 subjects | |||||
2. Operation time (min): mean±SD (range), 89.6±37.5 (36-176) | 2. >3/4 to <1: 7 subjects | ||||
3. =1: 5 subjects | |||||
None | 1. Size of resected specimen (mm): mean±SD (range), 62±17 (39-101) | Circumferential extent | |||
1. >2/3 to <3/4: 6 subjects | |||||
2. Operation time (min): mean±SD (range), 88.3±44.5 (44-235) | 2. >3/4 to <1: 5 subjects | ||||
3. =1: 5 subjects | |||||
Ohki et al. (2012) [11] | Japan | Prospective open label, single arm, single center study | Transplantation of autologous cell sheets to ulcer surfaces via an endoscope | 1. ESD using a hook knife | Circumference |
2. Iodine staining to identify the site | 1. Half: 1 subject | ||||
3. Glycerol and carmine solution was injected to separate the mucosal layer | 2. Two third: 4 subjects | ||||
3. Three fourth: 3 subjects | |||||
4. Almost whole: 1 subject | |||||
Iizuka et al. (2015) [12] | Japan | Prospective, single center study | MCFP technique | 1. An EG450-RD5 endoscope and a dual knife for ESD | The whole esophageal circumference was divided into 12 equal subparts to measure the size of defect |
2. Glycerol with small amounts of indigo carmine and epinephrine for injection | 1. 7/12: 4 subjects | ||||
2. 8/12: 5 subjects | |||||
3. ICC200 high frequency generator for radiofrequency ablation | 3. 9/12: 4 subjects | ||||
4. 10/12: 1 subjects | |||||
5. 11/12: 1 subjects | |||||
Sakaguchi et al. (2015) [13] | Japan | Prospective pilot study, single arm, single center | PGA sheet deployment with fibrin glue | 1. ESD using dual knife | More than three quarter of esophageal circumference |
2. Chromoendoscopy using iodine staining to identify the site | |||||
3. Hyaluronic acid solution was injected submucosally | |||||
4. Size of resected specimen (mm): mean±SD, 53.8±8.8 | |||||
5. Total dissection time (min): mean±SD, 120±28.8 | |||||
Isomoto et al. (2011) [14] | Japan | Prospective study | EBD | 1. Resection size (mm): mean (range), 69 (43–94) | Full esophageal circumference |
2. Mucosal incision with flush knife under the Endo cut 1 mode, submucosal dissection with flush knife under the forced coagulation mode. Hemostatic forceps un soft coagulation mode used to stop achieve hemostasis. | |||||
Oral steroids (prednisolone) | 1. Resection size (mm): mean (range), 76.5 (70–81) | ||||
2. Mucosal incision with flush knife under the Endo cut 1 mode, submucosal dissection with flush knife under the forced coagulation mode. Hemostatic forceps in soft coagulation mode was used to achieve hemostasis. | |||||
Uno et al. (2012) [15] | Japan | Prospective study | EBD | Procedure time (min): mean±SD, 131.6±44.4 | Circumferential extent |
1. ≥3/4: 14 subjects | |||||
2. =1: 2 subjects | |||||
EBD+Tranilast | Procedure time (min): mean±SD, 122.5±37.7 | Circumferential extent | |||
1. ≥3/4: 12 subjects | |||||
2. =1: 3 subjects | |||||
Yamaguchi et al. (2011) [16] | Japan | Retrospective study | EBD | 1. Tumor size (mm): mean (range), 30.4 (9–67) | Circumferential extent |
2. Operation time (min): mean (range), 95.5 (47–168) | 1. ≥3/4: 19 subjects | ||||
2. =1: 3 subjects | |||||
Oral steroids (prednisolone) | 1. Tumor size (mm): mean (range), 33.4 (11–84) | Circumferential extent | |||
2. Operation time (min): mean (range), 93.9 (40–260) | 1. ≥3/4: 16 subjects | ||||
2. =1: 3 subjects | |||||
Wen et al. (2014) [17] | China | Prospective, randomized controlled study | Covered esophageal metal stent placement (composed of high elastic stainless steel and is covered with high intensity medical silicone membrane) | ESD procedure time (min): mean (range), 310.2±106.7 | Circumferential extent |
1. ≥3/4: 5 subjects | |||||
2. ≥4/5: 2 subjects | |||||
3. =1: 4 subjects | |||||
No stent placed | ESD procedure time (min): mean (range), 265.1±106.0 | Circumferential extent | |||
1. ≥3/4: 6 subjects | |||||
2. ≥4/5: 3 subjects | |||||
3. =1: 2 subjects | |||||
Lee et al. (2013) [18] | Korea | Case report | Endoscopic Intralesional steroid (triamcinolone acetonide) injection, diluted with saline to make 20 mg/mL solution | 1. Mucosal incision and dissection were performed with a hook knife and an IT knife | Near full esophageal circumference |
2. 80 mL of normal saline mixed with epinephrine was injected to lift the mucosa including the tumor | |||||
3. Bleeding controlled with hemostatic forceps | |||||
4. Total time: 55 minutes |
Study | Country | Study type | Intervention to prevent esophageal stricture development | Monitoring and F/U | Stricture criteria |
---|---|---|---|---|---|
Hashimoto et al. (2011) [7] | Japan | Prospective study | ETI, 10 mg/mL solution | Esophagoscopy routinely at 1 week, 1, 6 months, and 1 year post-ETI, clinical F/U for dysphagia | Standard endoscope GIF-Q240 cannot pass through the ESD scar |
Historical control group (no intervention) | NA | ||||
Hanaoka et al. (2012) [8] | Japan | Prospective study | Endoscopic Intralesional steroid (triamcinolone acetonide) injection, diluted with saline to make 5 mg/mL solution | Endoscopy (EGD) routinely at 2 months post-ESD or earlier if dysphagia was reported | Dysphagia to solids (dysphagia score 2) or an inability to pass a >9.2 mm diameter endoscope |
Historical control group (no intervention) | NA | ||||
Mori et al. (2013) [9] | Japan | Prospective, randomized study | Local steroid injection and balloon dilation | Gastrograffin esophagograms on day 5, 8, 12, 15, 20, 30, 60 and clinical F/U for dysphagia | Inability to pass a 10 mm diameter endoscope through ESD scar in a patient complaining of dysphagia and requiring EBD |
Steroid gel application and balloon dilation | |||||
Takahashi et al. (2015) [10] | Japan | Prospective randomized controlled, open label, single center study | Endoscopic steroid injection therapy | 1. EGD, 6 days post-injection therapy | Esophageal diameter <11 mm or inability to achieve or maintain a diameter of 14 mm despite dilatation every 2–4 weeks |
2. Barium contrast esophagography in patients complaining of dysphagia or 4 weeks after the last EGD if patients were asymptomatic | |||||
None | Barium contrast esophagogra-phy in patients complaining of dysphagia or 4 weeks after the last EGD if patients were asymptomatic | ||||
Ohki et al. (2012) [11] | Japan | Prospective open label, single arm, single center study | Transplantation of autologous cell sheets to ulcer surfaces via an endoscope | Weekly endoscopy until epithelialization was complete | NA |
Iizuka et al. (2015) [12] | Japan | Prospective, single center study | MCFP technique | EGD at 1,2,4, and 6 weeks after ESD F/U (day): median (range), 352 (60-535) | Inability to pass H260 endoscope through the ESD scar |
Sakaguchi et al. (2015) [13] | Japan | Prospective pilot study, single arm, single center | PGA sheet deployment with fibrin glue | Scheduled endoscopy on day 7 and 28 or if clinically indicated based on symptom | Inability to pass 9.8 mm diameter endoscope (GIF Q240 or GIF H260) through the ESD scar |
Isomoto et al. (2011) [14] | Japan | Prospective study | EBD | 1. F/U endoscopy with iodine staining and biopsy if abnormal mucosa noted at 3, 6, and 12 months post-ESD | NA |
2. CT scan of cervix, thorax and abdomen at 3, 6 and 12 months post-ESD | |||||
3. Clinical F/U for dysphagia | |||||
Oral steroids (prednisolone) | |||||
Uno et al. (2012) [15] | Japan | Prospective study | EBD | 1. Scheduled consultations and F/U examinations by EGD (earlier if clinically warranted) for 48 weeks | Inability to pass 10.8 mm standard endoscope through the suspected esophageal region |
3. F/U period: mean±SD, 28.4±11.9 months | |||||
EBD+Tranilast | 1. Scheduled consultations and F/U examinations by EGD (earlier if clinically warranted) for 48 weeks | ||||
2. For tranilast- physical examination and blood work up including complete blood count, hepatic and kidney function tests weekly for first 4 weeks, and thereafter at 8, 16,24, and 48 weeks post-ESD | |||||
3. F/U period: mean±SD, 24.3±7.4 months | |||||
Yamaguchi et al. (2011) [16] | Japan | Retrospective study | EBD | 1. F/U endoscopy with iodine staining and biopsy if abnormal mucosa noted at 1, 3, 6, and 12 months post-ESD | NA |
2. CT scan of neck, chest and abdomen annually, post-ESD | |||||
3. Clinical F/U for dysphagia | |||||
Oral steroids (prednisolone) | |||||
Wen et al. (2014) [17] | China | Prospective, randomized controlled study | Covered esophageal metal stent placement (composed of high elastic stainless steel and is covered with high intensity medical silicone membrane) | 1. Routine F/U gastroscopy was done, 4 weeks post-ESD | <9.8 mm opening that did not permit the passage of GIF H260 endoscope through it |
2. Routine F/U endoscopy was done at 12 weeks post-ESD or when patient exhibited dysphagia symptoms to solid food | |||||
No stent placed | Routine F/U endoscopy was done at 12 weeks post-ESD or when patient exhibited dysphagia symptoms to solid food | ||||
Lee et al. (2013) [18] | Korea | Case report | Endoscopic intralesional steroid (triamcinolone acetonide) injection, diluted with saline to make 20 mg/mL solution | Esophagography at 2 and 4 weeks, EGD at 4 months post-ESD, clinical F/U for dysphagia | NA |
SCC, squamous cell cancer; ESD, endoscopic submucosal dissection; EBD, endoscopic balloon dilation; NA, not available; TA, triamcinolone acetonide; CT, computed tomography; HbA1c, glycated hemoglobin; DM, diabetes mellitus; MCFP, mucosal defect covered with fibrin glue and polyglycolic acid; PGA, polyglycolic acid; CRE, controlled radial expansion; GI, gastrointestinal; EMR, endoscopic mucosal resection; IQR, interquartile range.
ESD, endoscopic submucosal dissection; ETI, endoscopic triamcinolone injection; MCFP, mucosal defect covered with fibrin glue and polyglycolic acid; PGA, polyglycolic acid; EBD, endoscopic balloon dilation; NA, not available.
ETI, endoscopic triamcinolone injection; F/U, follow-up; EGD, esophagogastroduodenoscopy; ESD, endoscopic submucosal dissection; EBD, endoscopic balloon dilation; NA, not available. MCFP, mucosal defect covered with fibrin glue and polyglycolic acid; PGA, polyglycolic acid; CT, computed tomography.