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

Kazunori Nakaoka; Senju Hashimoto; Naoto Kawabe; Takuji Nakano; Toshiki Kan; Masashi Ohki; Yuka Ochi; Tomoki Takamura; Takamitsu Kurashita; Sayuri Nomura; Keishi Koyama; Aiko Fukui; Kentaro Yoshioka

doi:10.1055/a-0627-7078

Endoscopy International Open, Table of Contents

CC BY-NC-ND 4.0 · Endosc Int Open 2018; 06(10): E1164-E1170
DOI: 10.1055/a-0627-7078

Original article

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

Authors

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

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.

Full Text

References

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