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A Japanese prospective multicenter study of self-expandable metal stent placement for malignant colorectal obstruction: short-term safety and efficacy within 7 days of stent procedure in 513 cases - 01/06/16

Doi : 10.1016/j.gie.2015.03.1978 
Takeaki Matsuzawa, MD 1, Hideyuki Ishida, MD 1, Shuntaro Yoshida, MD 2, Hiroyuki Isayama, MD 3, Toshio Kuwai, MD 4, Iruru Maetani, MD 5, Mamoru Shimada, MD 6, Tomonori Yamada, MD 7, Shuji Saito, MD 8, Masafumi Tomita, MD 9, Koichi Koizumi, MD 10, Nobuto Hirata, MD 11, Takashi Sasaki, MD 12, Toshiyuki Enomoto, MD 13, Yoshihisa Saida, MD 13, ⁎
1 Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan 
2 Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan 
3 Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan 
4 Department of Gastroenterology, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, Kure, Japan 
5 Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Ohashi Medical Center, Tokyo, Japan 
6 Department of Surgery, Moriguchi Keijinkai Hospital, Osaka, Japan 
7 Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan 
8 Department of Surgery, National Hospital Organization Yokohama Medical Center, Yokohama, Japan 
9 Department of Surgery, Kishiwada Tokushukai Hospital, Osaka, Japan 
10 Department of Gastroenterology, Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital, Tokyo, Japan 
11 Department of Gastroenterology, Kameda Medical Center, Kamogawa, Japan 
12 Department of Gastroenterology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan 
13 Department of Surgery, Toho University Ohashi Medical Center, Tokyo, Japan 

∗Reprint requests: Yoshihisa Saida, MD, Department of Surgery, Toho University Ohashi Medical Center, 2-17-6 Ohashi, Meguro-ku, Tokyo 153-8515, Japan.

Abstract

Background

Endoscopic self-expandable metal stent placement has been used as an alternative to surgery for malignant colorectal obstruction; however, factors affecting its clinical outcome are unclear.

Objective

To clarify the short-term safety and efficacy of endoscopic self-expandable metal stent placement for malignant colorectal obstruction and to identify factors associated with its clinical and technical failure.

Design

Prospective clinical cohort study.

Setting

Fourteen academic centers and 32 community hospitals.

Patients

A total of 513 consecutive patients with malignant colorectal obstruction.

Intervention

Endoscopic self-expandable metal stent placement, sharing of stent placement methods among participating facilities.

Main Outcome Measurements

The primary endpoint was clinical success, defined as symptom and radiological finding resolution within 24 hours. Secondary endpoints were technical success and adverse events. The follow-up period was 7 days.

Results

The clinical and technical success rates were 95.5% and 97.9%, respectively. Major adverse events included perforation (2.1%), stent migration (1.0%), and stent occlusion (0.8%). The main causes of perforation were the procedure itself (0.8%) and comorbidities (obstructive colitis and impending perforation) not apparent before stent placement (0.6%). Extrinsic tumor origin was independently associated with the clinical failure after stent placement (odds ratio 4.23; 95% confidence interval, 1.21-14.79; P = .02). Stricture marking trended toward a negative association with technical failure (P = .09).

Limitations

Noncomparative study.

Conclusion

Strict inclusion criteria and stricture marking may improve the technical and clinical success of stent placement.

Il testo completo di questo articolo è disponibile in PDF.

Abbreviations : BTS, CROSS, PAL, PS, SEMS


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 DISCLOSURE: Dr Matsu has received personal fees from Boston Scientific Japan. Dr Yoshida has received personal fees from Boston Scientific Japan, Century Medical Inc, and ZEON. Dr Isayama has received donations and fees from Boston Scientific Japan, Century Medical Inc, and Taewong Medical. Dr Kuwai has received personal fees from Boston Scientific Japan, Dr Maetani has received personal frees from Boston Scientific Japan, Century Medical Inc, Piolax Medical Devices, and MC Medica. Dr Shimada has received personal fees from Boston Scientific Japan. Dr Saito has received personal fees from Boston Scientific Japan and Century Medical Inc. Dr Koizuma has received personal fees from Century Medical Inc and Olympus Medical Systems. Dr Sasaki has received personal fees from Boston Scientific Japan and Piolax Medical Devices. Dr Saida has received grants and personal fees from Boston Scientific Japan, Century Medical Inc, and Olympus Medical Systems. All other authors disclosed no financial relationships relevant to this publication.
 See CME section; p. 718.


© 2015  American Society for Gastrointestinal Endoscopy. Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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