Clinical Endoscopy

The Korean Society of Gastrointestinal Endoscopy (대한소화기내시경학회)
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A novel fully covered metal stent for unresectable malignant distal biliary obstruction: results of a multicenter prospective study

  • Arata Sakai (Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine) ;
  • Atsuhiro Masuda (Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine) ;
  • Takaaki Eguchi (Department of Gastroenterology and Hepatology, Osaka Saiseikai Nakatsu Hospital) ;
  • Keisuke Furumatsu (Department of Gastroenterology, Akashi Medical Center) ;
  • Takao Iemoto (Department of Gastroenterology, Kita-Harima Medical Center) ;
  • Shiei Yoshida (Department of Gastroenterology, Kobe Medical Center) ;
  • Yoshihiro Okabe (Department of Gastroenterology, Kakogawa Central City Hospital) ;
  • Kodai Yamanaka (Division of Gastroenterology, Konan Medical Center) ;
  • Ikuya Miki (Department of Gastroenterology, Hyogo Cancer Center) ;
  • Saori Kakuyama (Department of Gastroenterology, Takatsuki General Hospital) ;
  • Yosuke Yagi (Department of Internal Medicine, Shiso Municipal Hospital) ;
  • Daisuke Shirasaka (Department of Gastroenterology, Kobe Red Cross Hospital) ;
  • Shinya Kohashi (Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine) ;
  • Takashi Kobayashi (Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine) ;
  • Hideyuki Shiomi (Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine) ;
  • Yuzo Kodama (Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine)
  • Received : 2023.01.28
  • Accepted : 2023.04.18
  • Published : 2024.05.30
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Abstract

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.

Keywords

Acknowledgement

This work was supported by JSPS KAKENHI (grant number JP19K07938 [AS]). The study sponsors did not play any role in the study design, collection, analysis, and interpretation of the data, or in writing the report.

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