title: 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.
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.
  
  
  METHODS
  Prospective clinical cohort study.
  
  
  METHODS
  Fourteen academic centers and 32 community hospitals.
  
  
  METHODS
  A total of 513 consecutive patients with malignant colorectal obstruction.
  
  
  METHODS
  Endoscopic self-expandable metal stent placement, sharing of stent placement methods among participating facilities.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  Noncomparative study.
  
  
  CONCLUSIONS
  Strict inclusion criteria and stricture marking may improve the technical and clinical success of stent placement.
authors.affiliation: Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
authors.forename: Takeaki
authors.initials: T
authors.lastname: Matsuzawa
authors.affiliation: Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Ishida
authors.affiliation: Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Shuntaro
authors.initials: S
authors.lastname: Yoshida
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Isayama
authors.affiliation: Department of Gastroenterology, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, Kure, Japan.
authors.forename: Toshio
authors.initials: T
authors.lastname: Kuwai
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.
authors.forename: Iruru
authors.initials: I
authors.lastname: Maetani
authors.affiliation: Department of Surgery, Moriguchi Keijinkai Hospital, Osaka, Japan.
authors.forename: Mamoru
authors.initials: M
authors.lastname: Shimada
authors.affiliation: Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan.
authors.forename: Tomonori
authors.initials: T
authors.lastname: Yamada
authors.affiliation: Department of Surgery, National Hospital Organization Yokohama Medical Center, Yokohama, Japan.
authors.forename: Shuji
authors.initials: S
authors.lastname: Saito
authors.affiliation: Department of Surgery, Kishiwada Tokushukai Hospital, Osaka, Japan.
authors.forename: Masafumi
authors.initials: M
authors.lastname: Tomita
authors.affiliation: Department of Gastroenterology, Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital, Tokyo, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Koizumi
authors.affiliation: Department of Gastroenterology, Kameda Medical Center, Kamogawa, Japan.
authors.forename: Nobuto
authors.initials: N
authors.lastname: Hirata
authors.affiliation: Department of Gastroenterology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Sasaki
authors.affiliation: Department of Surgery, Toho University Ohashi Medical Center, Tokyo, Japan.
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Enomoto
authors.affiliation: Department of Surgery, Toho University Ohashi Medical Center, Tokyo, Japan.
authors.forename: Yoshihisa
authors.initials: Y
authors.lastname: Saida
mesh_terms: D000328:Adult; D000368:Aged; D015179:Colorectal Neoplasms / Q000150:complications*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007415:Intestinal Obstruction / Q000209:etiology / Q000628:therapy*; D007564:Japan; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D000069322:Self Expandable Metallic Stents; D016896:Treatment Outcome