Clinical Endoscopy

Original Article

A novel fully covered metal stent for unresectable malignant distal biliary obstruction: results of a multicenter prospective study: Arata Sakai, Atsuhiro Masuda, Takaaki Eguchi, Keisuke Furumatsu, Takao Iemoto, Shiei Yoshida, Yoshihiro Okabe, Kodai Yamanaka, Ikuya Miki, Saori Kakuyama, Yosuke Yagi, Daisuke Shirasaka, Shinya Kohashi, Takashi Kobayashi, Hideyuki Shiomi, Yuzo Kodama; Clin Endosc 2024;57(3):375-383. Published online July 10, 2023; DOI: https://doi.org/10.5946/ce.2023.035

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Background
/Aims: Endoscopic self-expandable metal stent (SEMS) placement is currently the standard technique for treating unresectable malignant distal biliary obstructions (MDBO). Therefore, covered SEMS with longer stent patency and fewer migrations are required. This study aimed to assess the clinical performance of a novel, fully covered SEMS for unresectable MDBO.
Methods
This was a multicenter single-arm prospective study. The primary outcome was a non-obstruction rate at 6 months. The secondary outcomes were overall survival (OS), recurrent biliary obstruction (RBO), time to RBO (TRBO), technical and clinical success, and adverse events.
Results
A total of 73 patients were enrolled in this study. The non-obstruction rate at 6 months was 61%. The median OS and TRBO were 233 and 216 days, respectively. The technical and clinical success rates were 100% and 97%, respectively. Furthermore, the rate of occurrence of RBO and adverse events was 49% and 21%, respectively. The length of bile duct stenosis (<2.2 cm) was the only significant risk factor for stent migration.
Conclusions
The non-obstruction rate of a novel fully covered SEMS for MDBO is comparable to that reported earlier but shorter than expected. Short bile duct stenosis is a significant risk factor for stent migration.

Citations

Citations to this article as recorded by

Percutaneous metallic stent placement for malignant extrahepatic biliary obstruction: single-center experience in 612 patients
Jihoon Kim, Dong Il Gwon, Jeongyeon Kim, Eunbyeol Ko, Jin Hyoung Kim, Gi-Young Ko, Hyun-Ki Yoon
Acta Radiologica.2026; 67(4): 352. CrossRef
Clinical Outcomes and Complications of Endoscopic Biliary Stenting for Malignant Distal Biliary Obstruction in Pancreatic Cancer: A Systematic Review
Nurken Abdiyev, Nurlan Jaxymbayev, Melis Maira, Medet Rakhmetov, Almas Ismailov, Abdykadyrov Mazhit, Yerlan Abdirashev, Berik Dzhumabekov
Journal of Clinical Medicine.2026; 15(8): 3126. CrossRef
The anti‐migration effect of partially covered self‐expandable metal stents for unresectable malignant distal biliary obstruction: A multicenter comparative study
Shinya Kohashi, Arata Sakai, Keisuke Furumatsu, Takeshi Ezaki, Takao Iemoto, Takeshi Tanaka, Masahiro Tsujimae, Takashi Kobayashi, Atsuhiro Masuda, Yuzo Kodama
DEN Open.2025;[Epub] CrossRef
Prevention of stent migration of covered self-expandable metal stents in distal malignant biliary obstruction: a review of literature
Jung Won Chun, Woo Hyun Paik, Sang Myung Woo, Jin Ho Choi, In Rae Cho, Woo Jin Lee, Ji Kon Ryu, Yong-Tae Kim, Sang Hyub Lee
Gastroenterology Report.2025;[Epub] CrossRef
From dogma to individualized care: the potential of 6-mm fully covered self-expandable metal stent in unresectable malignant distal biliary obstruction
Hyung Ku Chon
Clinical Endoscopy.2025; 58(4): 630. CrossRef
Advancements in stent strategies for malignant distal biliary obstruction: defining the clinical role of multi-hole self-expandable metal stents
Sung Yong Han
Clinical Endoscopy.2025; 58(5): 698. CrossRef
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Clinical Endoscopy.2023; 56(5): 592. CrossRef

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Migration of a Biliary Self-Expanding Metal Stent into the Stomach after Stent Placement in a Patient with Periampullary Cancer: Sung Ho Ki, M.D., Seok Jeong, M.D., Don Haeng Lee, M.D.*, Jung Il Lee, M.D., Jin-Woo Lee, M.D., Hyung Gil Kim, M.D., Yong Woon Shin, M.D. and Young Soo Kim, M.D.; Korean J Gastrointest Endosc 2008;36(5):324-327. Published online May 30, 2008

Abstract PDF: Migration of a biliary self-expanding metallic stent (SEMS) may occur proximally or distally after placing a stent for the palliative treatment of patients with unresectable periampullary malignancy. However, migration of a biliary SEMS into the stomach has not yet reported in the English medical literature. Herein we report on a case of periampullary cancer for which a stent that was placed to treat this malady migrated into the stomach. A biliary SEMS had been placed in the distal common bile duct in an 82-year-old woman who was diagnosed with periampullary cancer. The abdominal CT and esophagogastroduodenoscopic findings disclosed that the biliary SEMS had migrated into the stomach and there was marked luminal narrowing of the second portion of the duodenum due to the enlarged periampullary tumor. The migrated stent was easily removed by using a polypectomy snare. We presume that the distally migrated SEMS might have moved into the stomach against the normal direction of peristaltic movement instead of migrating to the intestine because of the duodenal obstruction caused by the growing mass. (Korean J Gastrointest Endosc 2008;36:324-328)

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인공식도관 일탈 방지를 위해 새로 고안한 막 부착형 금속형 인공식도관의 유용성 ( A Prospective Clinical Trial of the Newly Designed Esophageal Covered Metal Stent for Prevention of Stent Migration ): Korean J Gastrointest Endosc 1999;19(5):700-705. Published online November 30, 1998

Abstract PDF: Background
/Aims: Palliation of malignant esophageal obstructions consists mainly of symptomatic treatment of dysphagia. For this purpose, variable self expandable esophageal stents have recently been used. Of these stents, membrane covered self expandable metal stents (SEMS) are effective to prevent tumor ingrowth and stent obstruction. But migration is the main problem of covered SEMS. So we made a newly designed covered SEMS for the prevention of stent migration and studied prospectively to define its palliative ability and whether this stent is effective for prevention of migration problems. Methods: From January to December 1998, 27 patients [23 men, 4 women; mean age 60 years, range 20 to 80] were inserted with newly designed esophageal stents and studied. Data analysis included the location and length of malignant strictures, the length of the inserted esophageal stents, the time for fixation of the stents after insertion, complications related to stent insertion, and the effectiveness of the newly designed stent for prevention of the stent migration. Results: 1) The location of esophageal strictures were 4 in the mid- esophagus (three tracheo-esophageal fistula due to two lung and one esophageal cancer, one esophageal cancer), 7 in the distal esophagus (all esophageal cancer), and 16 in the esophagogastric junction (6 cases of esophageal cancer, 9 with gastric cardiac cancer, and 1 with gastric lymphoma). 2) The mean length of the strictures was 5.2 (3 to 12) cm. 3) The mean length of the stents was 11 (8 to 16) cm. 4) Time for fixation of the stents was 7.2 (5 to 13) days after the stent insertion. 5) Stent placement was successful in all patients without any serious stent-related complications such as esophageal perforation or hemorrhage. During the mean follow-up period of 6 (1 to 12) months, there was no stent migration. Conclusions: The newly designed covered SEMS was very effective in preventing stent migration without any serious stent-related complications, especially in malignant strictures of the esophagogastric junction, short segment strictures, and T-E fistulas without tumor shoulder. (Korean J Gastrointest Endosc 19: 700∼705, 1999)

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위나 직장으로 미입된 EsophaCoil TM 배액관의 새로운 내시경적 제거술에 대한 고찰 ( Clicical Evaluation of a Novel Method for Endoscopic Removal of an EsophaCoil TM Stent which Migrated into the Stomach and Rectum ): Korean J Gastrointest Endosc 1999;19(4):531-536. Published online November 30, 1998

Abstract PDF: Background
/Aims: The coiled stent is designed to allow removal in the event that stent malposition or migration occurs in patients with an inoperable malignant esophageal obstruction. There is limited published material on the EsophaCoilTM, especially with regard to its removability. A novel method for endoscopic removal of migrated EsophaCoilTM prosthesis is herein described. Methods: Seven instances of migration occurred in 19 patients who had undergone coiled stent placement for carcinoma of the distal esophagus or gastric cardia. The stents had migrated into the stomach in 6 cases and the stent was at the rectosigmoid junction in 1 patient. The migrated stents were removed endoscopically using a conventional method in 3 cases, and the Song's stent introducer with a metal tip and overtube under fluoroscopic guidance, in the remaining 4 patients. Results: Using the new endoscopic removal technique, migrated stents were successfully removed in 4 patients after conventional methods failed. There were no complications. Conclusions: An EsophaCoilTM stent, migrating into the stomach or rectum, could be removed easily by this new method using the overtube and Song's stent introducer. (Korean J Gastrointest Endosc 19: 531∼536, 1999)

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