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.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Division of Surgery, Gastrointestinal Center, Yokohama Shin-Midori General Hospital, 1726-7 Tokaichiba-cho, Midori-ku, Yokohama, 226-0025, Japan. shusaito@jb3.so-net.ne.jp.
authors.forename: Shuji
authors.initials: S
authors.lastname: Saito
authors.affiliation: Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.
authors.forename: Shuntaro
authors.initials: S
authors.lastname: Yoshida
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Isayama
authors.affiliation: Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Moroyama, Japan.
authors.forename: Takeaki
authors.initials: T
authors.lastname: Matsuzawa
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, Moriguchi, 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, Kishiwada Tokushukai Hospital, Kishiwada, 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 Surgery, National Hospital Organization Sagamihara Hospital, Sagamihara, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Kanazawa
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, National Hospital Organization Yokohama Medical Center, Yokohama, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Sekido
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; D000369:Aged, 80 and over; D003110:Colonic Neoplasms / Q000150:complications*; D017558:Elective Surgical Procedures; D004630:Emergencies; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007415:Intestinal Obstruction / Q000209:etiology* / Q000601:surgery*; D007564:Japan; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011446:Prospective Studies; D012004:Rectal Neoplasms / Q000150:complications*; D000069322:Self Expandable Metallic Stents
keywords: Bridge to surgery; Colon and rectal cancer; Intestinal obstruction; Multicenter study; Prospective cohort study; Self-expandable metallic stent