Adverse events of self-expandable metal stent placement for malignant distal biliary obstruction: a large multicenter study

Takashi Tamura; Takuo Yamai; Norimitsu Uza; Tomoaki Yamasaki; Atsuhiro Masuda; Fumimasa Tomooka; Hirotsugu Maruyama; Minoru Shigekawa; Takeshi Ogura; Katsutoshi Kuriyama; Masanori Asada; Hisakazu Matsumoto; Mamoru Takenaka; Koichiro Mandai; Yui Osaki; Kengo Matsumoto; Tsuyoshi Sanuki; Hideyuki Shiomi; Yosuke Yamagata; Toshifumi Doi; Osamu Inatomi; Fumihiko Nakanishi; Tomoya Emori; Masaaki Shimatani; Satoshi Asai; Seiji Fujigaki; Toshio Shimokawa; Masayuki Kitano

doi:10.1016/j.gie.2023.08.004

Adverse events of self-expandable metal stent placement for malignant distal biliary obstruction: a large multicenter study

Gastrointest Endosc. 2024 Jan;99(1):61-72.e8. doi: 10.1016/j.gie.2023.08.004. Epub 2023 Aug 19.

Authors

Takashi Tamura¹, Takuo Yamai², Norimitsu Uza³, Tomoaki Yamasaki⁴, Atsuhiro Masuda⁵, Fumimasa Tomooka⁶, Hirotsugu Maruyama⁷, Minoru Shigekawa⁸, Takeshi Ogura⁹, Katsutoshi Kuriyama¹⁰, Masanori Asada¹¹, Hisakazu Matsumoto¹², Mamoru Takenaka¹³, Koichiro Mandai¹⁴, Yui Osaki¹⁵, Kengo Matsumoto¹⁶, Tsuyoshi Sanuki¹⁷, Hideyuki Shiomi¹⁸, Yosuke Yamagata¹⁹, Toshifumi Doi²⁰, Osamu Inatomi²¹, Fumihiko Nakanishi²², Tomoya Emori²³, Masaaki Shimatani²⁴, Satoshi Asai²⁵, Seiji Fujigaki²⁶, Toshio Shimokawa²⁷, Masayuki Kitano¹

Affiliations

¹ Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
² Department of Hepatobiliary and Pancreatic Oncology, Osaka International Cancer Institute, Osaka, Japan.
³ Department of Gastroenterology and Hepatology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
⁴ Department of Gastroenterology, Osaka City General Hospital, Osaka, Japan.
⁵ Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Hyogo, Japan.
⁶ Department of Gastroenterology, Nara Medical University, Nara, Japan.
⁷ Department of Gastroenterology, Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan.
⁸ Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan.
⁹ Endoscopic Center, Osaka Medical and Pharmaceutical University Hospital, Osaka, Japan.
¹⁰ Department of Gastroenterology and Hepatology, Medical Research Institute Kitano Hospital, PIIF Tazuke-Kofukai, Osaka, Japan.
¹¹ Department of Gastroenterology and Hepatology, Japanese Red Cross Osaka Hospital, Osaka, Japan.
¹² Gastroenterology and Hepatology, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan.
¹³ Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.
¹⁴ Department of Gastroenterology, Kyoto Second Red Cross Hospital, Kyoto, Japan.
¹⁵ Department of Gastroenterology, Nara Prefecture Seiwa Medical Center, Nara, Japan.
¹⁶ Department of Gastroenterology, Toyonaka Municipal Hospital, Toyonaka, Osaka, Japan.
¹⁷ Department of Gastroenterology, Kita-harima Medical Center, Hyogo, Japan.
¹⁸ Division of Gastroenterology and Hepatobiliary and Pancreatic Diseases, Department of Internal Medicine, Hyogo Medical University, Nishinomiya, Hyogo, Japan.
¹⁹ Department of Gastroenterology and Hepatology, Yodogawa Christian Hospital, Osaka, Japan.
²⁰ Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kamigyo-ku, Kyoto, Japan.
²¹ Division of Gastroenterology, Department of Medicine, Shiga University of Medical Science, Otsu, Shiga, Japan.
²² Department of Gastroenterology, National Hospital Organization Osaka, Minami Medical Center, Kawachinagano, Osaka, Japan.
²³ Department of Gastroenterology, Wakayama Rosai Hospital, Wakayama, Japan.
²⁴ Division of Gastroenterology and Hepatology, Kansai Medical University Medical Center, Moriguchi, Osaka, Japan.
²⁵ Department of Gastroenterology, Tane General Hospital, Osaka, Japan.
²⁶ Department of Gastroenterology, Steel Memorial Hirohata Hospital, Himeji, Hyogo, Japan.
²⁷ Clinical Study Support Center, Wakayama Medical University Hospital, Wakayama, Japan.

PMID: 37598864
DOI: 10.1016/j.gie.2023.08.004

Abstract

Background and aims: Endoscopic placement of self-expandable metal stents (SEMSs) for malignant distal biliary obstruction (MDBO) may be accompanied by several types of adverse events. The present study analyzed the adverse events occurring after SEMS placement for MDBO.

Methods: The present study retrospectively investigated the incidence and types of adverse events in patients who underwent SEMS placement for MDBO between April 2018 and March 2021 at 26 hospitals. Risk factors for acute pancreatitis, cholecystitis, and recurrent biliary obstruction (RBO) were evaluated by univariate and multivariate analyses.

Results: Of the 1425 patients implanted with SEMSs for MDBO, 228 (16.0%) and 393 (27.6%) experienced early adverse events and RBO, respectively. Pancreatic duct without tumor involvement (P = .023), intact papilla (P = .025), and SEMS placement across the papilla (P = .037) were independent risk factors for acute pancreatitis. Tumor involvement in the orifice of the cystic duct was an independent risk factor for cholecystitis (P < .001). Use of fully and partially covered SEMSs was an independent risk factor for food impaction and/or sludge. Use of fully covered SEMSs was an independent risk factor for stent migration. Use of uncovered SEMSs and laser-cut SEMSs was an independent risk factor for tumor ingrowth.

Conclusions: Pancreatic duct without tumor involvement, intact papilla, and SEMS placement across the papilla were independent risk factors for acute pancreatitis, and tumor involvement in the orifice of the cystic duct was an independent risk factor for cholecystitis. The risk factors for food impaction and/or sludge, stent migration, and tumor ingrowth differed among types of SEMSs.

Publication types

Multicenter Study

MeSH terms

Acute Disease
Bile Duct Neoplasms* / complications
Cholecystitis* / etiology
Cholecystitis* / surgery
Cholestasis* / etiology
Cholestasis* / surgery
Humans
Pancreatitis* / complications
Pancreatitis* / etiology
Retrospective Studies
Self Expandable Metallic Stents* / adverse effects
Sewage
Stents / adverse effects

Substances

Sewage