CC BY-NC-ND 4.0 · Endosc Int Open 2018; 06(10): E1164-E1170
DOI: 10.1055/a-0627-7078
Original article
Owner and Copyright © Georg Thieme Verlag KG 2018

Evaluation of a 12-mm diameter covered self-expandable end bare metal stent for malignant biliary obstruction

Kazunori Nakaoka
Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan
,
Senju Hashimoto
Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan
,
Naoto Kawabe
Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan
,
Takuji Nakano
Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan
,
Toshiki Kan
Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan
,
Masashi Ohki
Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan
,
Yuka Ochi
Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan
,
Tomoki Takamura
Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan
,
Takamitsu Kurashita
Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan
,
Sayuri Nomura
Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan
,
Keishi Koyama
Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan
,
Aiko Fukui
Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan
,
Kentaro Yoshioka
Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan
› Author Affiliations
Further Information

Publication History

submitted 04 December 2017

accepted after revision 27 April 2018

Publication Date:
08 October 2018 (online)

Abstract

Background and study aims Biliary metallic stents are used to drain unresectable malignant distal biliary obstructions. This study aimed to evaluate the efficacy of a novel 12-mm-diameter covered, self-expandable end bare metal stent (12-mm CSEEMS).

Patients and methods We evaluated 99 patients with unresectable malignant distal biliary obstructions treated with covered biliary metallic stents. Of the 99 patients, 33 underwent 12-mm CSEEMS placement between June 2015 and April 2017 (12-mm-CSEEMS group) and 66 underwent 10-mm fully-covered self-expandable metal stent (FCSEMS) placement between January 2010 and July 2015 (10-mm-FCSEMS group). The overall survival (OS), the recurrent biliary obstruction (RBO), cause of RBO, time to RBO (TRBO) and adverse events in 12-mm-CSEEMS group and 10-mm-FCSEMS group were evaluated retrospectively.

Results The OS tended to be longer in the 12-mm-CSEEMS group (log rank, P = 0.081) and TRBO was significantly longer in the 12-mm-CSEEMS group (log rank, P = 0.001) than in the 10-mm-FCSEMS group. Both univariate (HR, 0.449; 95 % CI, 0.27967 – 0.72215; P = 0.001) and multivariate (HR, 0.458; 95 % CI, 0.28395 – 0.73744; P = 0.001) Cox hazard analysis found that risk of RBO was significantly lower in 12-mm CSEEMS than in 10-mm FCSEMS. There were no significant differences between the 12-mm-CSEEMS group and 10-mm-FCSEMS group regarding the cause of RBO and adverse events.

Conclusions The 12-mm CSEEMS showed a low risk of RBO compared with 10-mm FCSEMS and was considered to be effective and safe for draining unresectable malignant distal biliary obstruction.