Retrospective Cohort Study
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Jan 16, 2018; 10(1): 16-22
Published online Jan 16, 2018. doi: 10.4253/wjge.v10.i1.16
New 14-mm diameter Niti-S biliary uncovered metal stent for unresectable distal biliary malignant obstruction
Masataka Kikuyama, Naofumi Shirane, Shinya Kawaguchi, Shuzou Terada, Tsuyoshi Mukai, Ken Sugimoto
Masataka Kikuyama, Naofumi Shirane, Shinya Kawaguchi, Shuzou Terada, Tsuyoshi Mukai, Ken Sugimoto, Department of Gastroenterology, Komagome Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo 113-8677, Japan
Naofumi Shirane, Department of Gastroenterology, Shizuoka General Hospital, Shizuoka 432-8021, Japan
Tsuyoshi Mukai, Department of Gastroenterology, Gifu Municipal Hospital, Gifu 500-8513, Japan
Ken Sugimoto, Department of Gastroenterology, Hamamatsu University School of Medicine, Shizuoka 113-8677, Japan
Author contributions: All authors have contributed to and agreed on the content of the manuscript; Kikuyama M, Shirane N and Kawaguchi S contributed to data collection; Terada S contributed to statistical analysis; Mukai T and Sugimoto K contributed to data collection.
Institutional review board statement: This study was approved by the institutional review aboards of Shizuoka General Hospital, Gifu Municipal Hospital, and Hamamatsu University Hospital.
Informed consent statement: All the treatment procedures were performed after obtaining the informed consent in writing from the patients.
Conflict-of-interest statement: Authors declare no conflicts of interest for this article.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Masataka Kikuyama, MD, PhD, Department of Gastroenterology, Komagome Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-15-22, Honkomagome, Bunnkyo-ku, Tokyo 113-8677, Japan. kikuyama110@cick.jp
Telephone: +81-3-38232101 Fax: +81-3-38235433
Received: June 30, 2017
Peer-review started: July 6, 2017
First decision: August 7, 2017
Revised: August 30, 2017
Accepted: November 3, 2017
Article in press: November 3, 2017
Published online: January 16, 2018
Processing time: 194 Days and 19.1 Hours
Abstract
AIM

To investigate whether an uncovered self-expandable metal stent (UCSEMS) with a large diameter could prevent recurrent biliary obstruction (RBO).

METHODS

Thirty-eight patients with malignant biliary obstruction underwent treatment with an UCSEMS with a 14-mm diameter (Niti-S 14). Retrospectively, we evaluated technical and functional success rate, RBO rate, time to RBO, survival time, and adverse events in these patients.

RESULTS

Stent placement success and functional success were achieved in all patients. Two patients (5.3%) had RBO due to tumor ingrowth or overgrowth. The median time to RBO was 190 (range, 164-215) d. The median survival time was 120 (range, 18-502) d. The 6-mo non-RBO rate was 91%. Other adverse events other than RBO occurred as follows: Acute cholecystitis, post-ERCP pancreatitis, hemobilia, and fever without exacerbation of liver injury, and liver abscess in 4 (10.3%), 3 (7.9%), 2 (5.3%), 1 (2.6%), and 1 (2.6%), respectively. Migration of the stents was not observed.

CONCLUSION

Niti-S 14 is considered to be a preferable metal stent because of a low rate of RBO with no migration.

Keywords: Metal stent; Malignant biliary obstruction; Pancreatic cancer; Migration; Pancreatitis; Bile duct cancer; Overgrowth; Recurrent biliary obstruction; Ingrowth; Adverse event

Core tip: Our manuscript reports on 38 patients with unresectable distal malignant biliary obstruction (MBO) treated with a newly developed 14-mm diameter Niti-S biliary uncovered metal stent. The results could show the stent is preferable for the palliate treatment of unresectable distal MBO because of a low rate of recurrent biliary obstruction, no migration, a low rate of other complications, and a high success rate of placement.