Clinical Endoscopy

Original Articles

Novel upper gastrointestinal bleeding sensor capsule: a first human feasibility and safety trial: Lukas Bajer, Marvin Ryou, Christopher C. Thompson, Pavel Drastich; Clin Endosc 2024;57(2):203-208. Published online January 17, 2024; DOI: https://doi.org/10.5946/ce.2023.111

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Background
/Aims: Upper gastrointestinal bleeding (UGIB) is the most common GI condition requiring hospitalization, and can be diagnosed by direct visualization. The present study aimed to evaluate the safety and feasibility of using the PillSense system (EnteraSense Ltd.), a novel diagnostic tool designed for the rapid in vivo detection of UGIB, in human volunteers.
Methods
In the present study, 10 volunteers swallowed a PillSense capsule, followed by 2 servings of an autologous blood preparation. Participants were monitored for capsule passage, overall tolerability of the procedure, and adverse events.
Results
The procedure was completed per the protocol established in the present study in 9/10 cases. In 9 of the subjects, after capsule ingestion, the device indicated the absence of blood with sensor output values of 1. After the ingestion of the first blood mixture, the sensor outputs of all devices increased from 2.8 to 4, indicating that each camera detected blood. The sensor output remained within that range after the ingestion of the second mixture; however, in one case, the baseline capsule signal was positive, because of a preexisting condition. The passage of the capsule was verified in all patients, and no adverse events were reported.
Conclusions
The first trial of the PillSense system in human subjects demonstrated the feasibility, safety, and tolerability of utilizing this product as a novel, noninvasive, and easy-to-use triage tool for the diagnosis of patients suspected of having UGIB.

Citations

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Could a bleeding-sensor device be established as a new paradigm for detecting upper gastrointestinal bleeding before performing endoscopy?
Sun Gyo Lim
Clinical Endoscopy.2024; 57(2): 191. CrossRef

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Preclinical study of a novel ingestible bleeding sensor for upper gastrointestinal bleeding: Kimberly F. Schuster, Christopher C. Thompson, Marvin Ryou; Clin Endosc 2024;57(1):73-81. Published online May 31, 2023; DOI: https://doi.org/10.5946/ce.2022.293

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Background
/Aims: Upper gastrointestinal bleeding (UGIB) is a life-threatening condition that necessitates early identification and intervention and is associated with substantial morbidity, mortality, and socioeconomic burden. However, several diagnostic challenges remain regarding risk stratification and the optimal timing of endoscopy. The PillSense System is a noninvasive device developed to detect blood in patients with UGIB in real time. This study aimed to assess the safety and performance characteristics of PillSense using a simulated bleeding model.
Methods
A preclinical study was performed using an in vivo porcine model (14 animals). Fourteen PillSense capsules were endoscopically placed in the stomach and blood was injected into the stomach to simulate bleeding. The safety and sensitivity of blood detection and pill excretion were also investigated.
Results
All the sensors successfully detected the presence or absence of blood. The minimum threshold was 9% blood concentration, with additional detection of increasing concentrations of up to 22.5% blood. All the sensors passed naturally through the gastrointestinal tract.
Conclusions
This study demonstrated the ability of the PillSense System sensor to detect UGIB across a wide range of blood concentrations. This ingestible device detects UGIB in real time and has the potential to be an effective tool to supplement the current standard of care. These favorable results will be further investigated in future clinical studies.

Citations

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Miniaturized Capsule System Toward Real‐Time Electrochemical Detection of H2S in the Gastrointestinal Tract
Justin M. Stine, Katie L. Ruland, Luke A. Beardslee, Joshua A. Levy, Hossein Abianeh, Santiago Botasini, Pankaj J. Pasricha, Reza Ghodssi
Advanced Healthcare Materials.2024;[Epub] CrossRef

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Editorial

Assessing implementation strategy and learning curve for transoral incisionless fundoplication as a new technique: Muhammad Haseeb, Christopher C. Thompson; Clin Endosc 2022;55(6):751-752. Published online November 8, 2022; DOI: https://doi.org/10.5946/ce.2022.280

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Citations

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Gastroesophageal reflux disease in children: What’s new right now?
Palittiya Sintusek, Mohamed Mutalib, Nikhil Thapar
World Journal of Gastrointestinal Endoscopy.2023; 15(3): 84. CrossRef
Endoscopic therapy for gastroesophageal reflux disease: where are we, where are we going?
Muhammad Haseeb, Christopher C. Thompson
Current Opinion in Gastroenterology.2023; 39(5): 381. CrossRef

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Original Articles

Determining the Safety and Effectiveness of Electrocautery Enhanced Scissors for Peroral Endoscopic Myotomy (with Video): Kelly E. Hathorn, Walter W. Chan, Hiroyuki Aihara, Christopher C. Thompson; Clin Endosc 2020;53(4):443-451. Published online May 22, 2020; DOI: https://doi.org/10.5946/ce.2019.214

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Background
/Aims: Peroral endoscopic myotomy (POEM) has recently come to the forefront in the management of achalasia. We aimed to analyze the efficacy and safety of the use of electrocautery enhanced scissors (EES) for POEM.
Methods
This retrospective cohort study prospectively collected the data of all adult patients (aged ≥18 years) with normal foregut anatomy who underwent POEM using EES. The patients’ baseline characteristics and procedure details (time, tunnel length, myotomy length, depth, and location) were recorded. The primary outcome was clinical success (3-month post-procedure Eckardt score of ≤3). The secondary outcomes were technical success and adverse events. A paired Student’s t-test was performed.
Results
Fifteen patients were included in this study. The technical success rate of myotomy using EES was 100%. Fellows participated in the myotomy in all cases. The clinical success rate was 93.3% (14/15). The mean pre-Eckardt score was 5.4±2.5, while the mean post-Eckardt score was 1.3±1.3, which indicated a significant improvement (p≤0.0001). The most common treatment-related adverse events were post-procedure pain (4, 26.7%) and symptomatic reflux disease (4, 26.7%).
Conclusions
In the largest series to date on the use of EES in POEM, we demonstrated that this technique has both technical and clinical efficacy as well as an excellent safety profile.

Citations

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Peroral endoscopic myotomy using an endoscopic dissector: another novel device in our toolbox
Shruti Mony, Apurva Shrigiriwar, Andrew Canakis, Mouen A. Khashab
VideoGIE.2023; 8(1): 5. CrossRef
Peroral endoscopic myotomy (POEM) is more cost-effective than laparoscopic Heller myotomy in the short term for achalasia: economic evaluation from a randomized controlled trial
Tatiana Morgado Conte, Luciana Bertocco de Paiva Haddad, Igor Braga Ribeiro, Eduardo Turiani Hourneaux de Moura, Luiz Augusto Carneiro DʼAlbuquerque, Eduardo Guimarães Hourneaux de Moura
Endoscopy International Open.2020; 08(11): E1673. CrossRef

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Effect of Aspiration Therapy on Obesity-Related Comorbidities: Systematic Review and Meta-Analysis: Pichamol Jirapinyo, Diogo T. H. de Moura, Laura C. Horton, Christopher C. Thompson; Clin Endosc 2020;53(6):686-697. Published online February 28, 2020; DOI: https://doi.org/10.5946/ce.2019.181

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Background
/Aims: Aspiration therapy (AT) involves endoscopic placement of a gastrostomy tube with an external device that allows patients to drain 30% of ingested calories after meals. Its efficacy for inducing weight loss has been shown. This study aimed to assess the effect of AT on obesity-related comorbidities.
Methods
A meta-analysis of studies that assessed AT outcomes was conducted through December 2018. Primary outcomes were changes in comorbidities at 1 year following AT. Secondary outcomes were the amount of weight loss at up to 4 years and pooled serious adverse events (SAEs).
Results
Five studies with 590 patients were included. At 1 year, there were improvements in metabolic conditions: mean difference (MD) in systolic blood pressure: -7.8 (-10.7 – -4.9) mm Hg; MD in diastolic blood pressure: -5.1 (-7.0 – 3.2) mm Hg; MD in triglycerides: -15.8 (-24.0 – -7.6) mg/dL; MD in high-density lipoprotein: 3.6 (0.7–6.6) mg/dL; MD in hemoglobin A1c (HbA1c): -1.3 (-1.8 – -0.8) %; MD in aspartate transaminase: -2.7 (-4.1 – -1.3) U/L; MD in alanine transaminase: -7.5 (-9.8 – -5.2) U/L. At 1 (n=218), 2 (n=125), 3 (n=46), and 4 (n=27) years, the patients experienced 17.8%, 18.3%, 19.1%, and 18.6% total weight loss (TWL), corresponding to 46.3%, 46.2%, 48.0%, and 48.7% excess weight loss (EWL) (p<0.0001 for all). Subgroup analysis of 2 randomized controlled trials (n=225) showed that AT patients lost more weight than did controls by 11.6 (6.5–16.7) %TWL and 25.6 (16.0–35.3) %EWL and experienced greater improvement in HbA1c and alanine transaminase by 1.3 (0.8–1.8) % and 9.0 (3.9–14.0) U/L. The pooled SAE rate was 4.1%.
Conclusions
Obesity-related comorbidities significantly improved at 1 year following AT. Additionally, a subgroup of patients who continued to use AT appeared to experience significant weight loss that persisted up to at least 4 years.

Citations

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Pichamol Jirapinyo, Christopher C. Thompson
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Amit Mehta, Reem Z. Sharaiha
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Jad Farha, Shahem Abbarh, Zadid Haq, Mohamad I. Itani, Andreas Oberbach, Vivek Kumbhari, Dilhana Badurdeen
Current Gastroenterology Reports.2020;[Epub] CrossRef

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Validation of a Novel Endoscopic Retrograde Cholangiopancreatography Cannulation Simulator: Pichamol Jirapinyo, Andrew C. Thompson, Hiroyuki Aihara, Marvin Ryou, Christopher C. Thompson; Clin Endosc 2020;53(3):346-354. Published online February 17, 2020; DOI: https://doi.org/10.5946/ce.2019.105

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Background
/Aims: Endoscopic retrograde cholangiopancreatography (ERCP) requires a unique skill set. Currently, there is no objective methodology to assess and train a professional to perform ERCP. This study aimed to develop and validate a novel ERCP simulator.
Methods
The simulator consists of papillae presenting different anatomy and positioned in varied locations. Deep cannulation of the pancreatic duct, followed by the bile duct, was performed. The time allotted was 5 minutes. The content validity indexes (CVIs) for realism, relevance, and representativeness were calculated. Correlation between ERCP experience and simulator score was determined.
Results
Twenty-three participants completed the simulation. The CVIs for realism were orientation of duodenoscope to papilla (1.00), angulation of papillotome to achieve cannulation (0.71), and haptic feedback during cannulation (0.80). The CVIs for relevance were use of elevator (1.00), wheels to achieve en face orientation (1.00), and papillotome for selective cannulation (1.00). Regarding CVI for representativeness, the results were as follows: basic cannulation (0.83), papilla locations (0.83), and papilla anatomies (0.80). The novice, intermediate, and experienced groups scored 6.7±8.7, 30.0±16.3, and 74.4±43.9, respectively (p<0.0001). There was a strong correlation between the ERCP experience level and the individual’s simulator score (Pearson value of 0.77, R2 of 0.60).
Conclusions
This simulator appears to be realistic, relevant, and representative of ERCP cannulation techniques. Additionally, it is effective at objectively assessing basic ERCP skills by differentiating scores based on clinical experience.

Citations

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Morfología de la papila de Vater como factor que influye en el éxito en canulación durante el entrenamiento del Residente en Endoscopia Avanzada. Estudio clínico prospectivo
D.E. Benavides-Salgado, R.A. Jiménez-Castillo, J.E. Cuéllar-Monterrubio, J.O. Jáquez-Quintana, A. Garza-Galindo, C. Cortes-Hernández, H.J. Maldonado-Garza, D. García-Compeán, J.A. González-González
Revista de Gastroenterología de México.2024; 89(2): 237. CrossRef
Papilla of Vater morphology as an influencing factor in successful cannulation during resident training in advanced endoscopy. A prospective clinical study
D.E. Benavides-Salgado, R.A. Jiménez-Castillo, J.E. Cuéllar-Monterrubio, J.O. Jáquez-Quintana, A. Garza-Galindo, C. Cortes-Hernández, H.J. Maldonado-Garza, D. García-Compeán, J.A. González-González
Revista de Gastroenterología de México (English Edition).2024; 89(2): 237. CrossRef
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Endoscopic Ultrasound Fine-Needle Aspiration versus Fine-Needle Biopsy for Lymph Node Diagnosis: A Large Multicenter Comparative Analysis: Diogo Turiani Hourneaux de Moura, Thomas R. McCarty, Pichamol Jirapinyo, Igor Braga Ribeiro, Galileu Ferreira Ayala Farias, Marvin Ryou, Linda S. Lee, Christopher C. Thompson; Clin Endosc 2020;53(5):600-610. Published online December 3, 2019; DOI: https://doi.org/10.5946/ce.2019.170

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Background
/Aims: Endoscopic ultrasound fine-needle aspiration (EUS-FNA) is preferred for sampling of lymph nodes (LNs) adjacent to the gastrointestinal wall; however, fine-needle biopsy (FNB) may provide improved diagnostic outcomes. This study aimed to evaluate the comparative efficacy and safety of FNA versus FNB for LN sampling.
Methods
This was a multicenter retrospective study of prospectively collected data to evaluate outcomes of EUS-FNA and EUS-FNB for LN sampling. Characteristics analyzed included sensitivity, specificity, accuracy, the number of needle passes, diagnostic adequacy of rapid on-site evaluation (ROSE), cell-block analysis, and adverse events.
Results
A total of 209 patients underwent EUS-guided LN sampling. The mean lesion size was 16.22±8.03 mm, with similar sensitivity and accuracy between FNA and FNB ([67.21% vs. 75.00%, respectively, p=0.216] and [78.80% vs. 83.17%, respectively, p=0.423]). The specificity of FNB was better than that of FNA (100.00% vs. 93.62%, p=0.01). The number of passes required for diagnosis was not different. Abdominal and peri-hepatic LN location demonstrated FNB to have a higher sensitivity (81.08% vs. 64.71%, p=0.031 and 80.95% vs. 58.33%, p=0.023) and accuracy (88.14% vs. 75.29%, p=0.053 and 88.89% vs. 70.49%, p=0.038), respectively. ROSE was a significant predictor for accuracy (odds ratio, 5.16; 95% confidence interval, 1.15–23.08; p=0.032). No adverse events were reported in either cohort.
Conclusions
Both EUS-FNA and EUS-FNB are safe for the diagnosis of LNs. EUS-FNB is preferred for abdominal LN sampling. EUSFNA+ ROSE was similar to EUS-FNB alone, showing better diagnosis for EUS-FNB than traditional FNA. While ROSE remained a significant predictor for accuracy, due to its poor availability in most centers, its use may be limited to cases with previous inconclusive diagnoses.

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Review

Endoscopic Ultrasound-Guided Fine Needle Aspiration and Endoscopic Retrograde Cholangiopancreatography-Based Tissue Sampling in Suspected Malignant Biliary Strictures: A Meta-Analysis of Same-Session Procedures: Diogo Turiani Hourneax de Moura, Marvin Ryou, Eduardo Guimarães Hourneaux de Moura, Igor Braga Ribeiro, Wanderlei Marques Bernardo, Christopher C. Thompson; Clin Endosc 2020;53(4):417-428. Published online November 5, 2019; DOI: https://doi.org/10.5946/ce.2019.053

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Background
/Aims: The diagnosis of biliary strictures can be challenging. There are no systematic reviews studying same-session endoscopic retrograde cholangiopancreatography (ERCP)-based tissue sampling and endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for the diagnosis of biliary strictures.
Methods
A systematic review was conducted on studies analyzing same-session EUS and ERCP for tissue diagnosis of suspected malignant biliary strictures. The primary outcome was the accuracy of each method individually compared to the two methods combined. The secondary outcome was the accuracy of each method in pancreatic and biliary etiologies. In the meta-analysis, we used Forest plots, summary receiver operating characteristic curves, and estimates of the area under the curve for intention-to-treat analysis.
Results
Of the 12,132 articles identified, six were included, resulting in a total of 497 patients analyzed. The sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and accuracy of the association between the two methods were: 86%, 98%, 12.50, 0.17, and 96.5%, respectively. For the individual analysis, the sensitivity, specificity and accuracy of EUS-FNA were 76%, 100%, and 94.5%, respectively; for ERCP-based tissue sampling, the sensitivity, specificity, and accuracy were 58%, 98%, and 78.1%, respectively. For pancreatic lesions, EUS-FNA was superior to ERCP-based tissue sampling. However, for biliary lesions, both methods had similar sensitivities.
Conclusions
Same-session EUS-FNA and ERCP-based tissue sampling is superior to either method alone in the diagnosis of suspected malignant biliary strictures. Considering these results, combination sampling should be performed when possible.

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