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01-09-2016

A prospective multicenter study on self-expandable metallic stents as a bridge to surgery for malignant colorectal obstruction in Japan: efficacy and safety in 312 patients

Authors: Shuji Saito, Shuntaro Yoshida, Hiroyuki Isayama, Takeaki Matsuzawa, Toshio Kuwai, Iruru Maetani, Mamoru Shimada, Tomonori Yamada, Masafumi Tomita, Koichi Koizumi, Nobuto Hirata, Hideki Kanazawa, Toshiyuki Enomoto, Hitoshi Sekido, Yoshihisa Saida

Published in: Surgical Endoscopy | Issue 9/2016

Abstract

Background

Endoscopic stenting with a self-expandable metallic stent (SEMS) is a widely accepted procedure for malignant colonic obstruction. The Colonic Stent Safe Procedure Research Group conducted the present prospective feasibility study.

Methods

Our objectives were to estimate the safety and feasibility of SEMS placement as a bridge to surgery (BTS) for malignant colorectal obstruction. We conducted a prospective, observational, single-arm, multicenter clinical trial from March 2012 to October 2013. Each patient was treated with an uncovered WallFlex enteral colonic stent. Patients were followed up until discharge after surgery.

Results

A total of 518 consecutive patients were enrolled in this study. The cohort intended for BTS consisted of 312 patients (61 %), and the stent could be released in 305 patients. Technical and clinical success rates were 98 and 92 %, respectively. Elective surgery was performed in 297 patients, and emergency surgery was performed in eight patients for the treatment of complications. The overall preoperative complication rate was 7.2 %. Major complications, including perforation, occurred in 1.6 %, persistent colonic obstruction occurred in 1.0 %, and stent migration occurred in 1.3 % patients. The median time from SEMS to surgery was 16 days. Silent perforations were observed in 1.3 %. Open and laparoscopic surgery was performed in 121 and 184 patients, respectively. The tumor could be resected in 297 patients. The primary anastomosis rate was 92 %. The rate of anastomotic leakage was 4 %, and the overall stoma creation rate was 10 %. The median duration of hospitalization following surgery was 12 days. Overall postoperative morbidity and mortality rates were 16 and 0.7 %, respectively.

Conclusions

This largest, multicenter, prospective study demonstrates the feasibility of SEMS placement as a BTS for malignant colorectal obstruction. SEMS serves as a safe and effective BTS with acceptable stoma creation and complication rates in patients with acute malignant colonic obstruction.

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Title: A prospective multicenter study on self-expandable metallic stents as a bridge to surgery for malignant colorectal obstruction in Japan: efficacy and safety in 312 patients
Authors: Shuji Saito
Shuntaro Yoshida
Hiroyuki Isayama
Takeaki Matsuzawa
Toshio Kuwai
Iruru Maetani
Mamoru Shimada
Tomonori Yamada
Masafumi Tomita
Koichi Koizumi
Nobuto Hirata
Hideki Kanazawa
Toshiyuki Enomoto
Hitoshi Sekido
Yoshihisa Saida
Publication date: 01-09-2016
Publisher: Springer US
Published in: Surgical Endoscopy / Issue 9/2016
Print ISSN: 0930-2794
Electronic ISSN: 1432-2218
DOI: https://doi.org/10.1007/s00464-015-4709-5

At a glance: The STEP trials

Springer Medicine

A prospective multicenter study on self-expandable metallic stents as a bridge to surgery for malignant colorectal obstruction in Japan: efficacy and safety in 312 patients

Abstract

Background

Methods

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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