Masafumi Tomita, MD1, Shuji Saito2, Shinichiro Makimoto1, Shuntaro Yoshida3, Hiroyuki Isayama3, Tomonori Yamada4, Takeaki Matsuzawa5, Toshiyuki Enomoto6, Kyo Rika7, Kuwai Toshio8, Nobuto Hirata9, Mamoru Shimada10, Tomio Hirakawa10, Koichi Koizumi11, Yoshihisa Saida6. 1Kishiwada Tokushukai Hospital, 2Division of Surgery, Gastrointestinal Center, Yokohama Shin-Midori General Hospital, 3Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo, 4Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, 5Department of Digestive and General Surgery, Uonuma Institute of Community Medicine, Niigata University Medical and Dental Hospital, 6Department of Surgery, Toho University Ohashi Medical Center, 7Department of Gastroenterology,Saiseikai Yokohamashi-Nanbu Hospital, 8Department of Gastroenterology, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, 9Department of Gastroenterology, Kameda Medical Center, 10Department of Surgery, Toyonaka Midorigaoka Hospital, 11Department of Gastroenterology, Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital
BACKGROUND: Japan Colonic Stent Safe Procedure Research Group conducted two prospective multicenter trials to evaluate the efficacy and safety of colonic stenting with two different types of self-expandable metallic stents (SEMS). We integrated the pooled data of these two trials to clarify the validity of colonic stenting as a bridge to surgery (BTS).
METHODS AND PROCEDURES: Two multicenter prospective, single-arm observational clinical trials evaluated the WallFlex Enteral Colonic Stent (Boston Scientific Corporation, March 2012 to October 2013) and the Niti-S colonic stent (TaeWoong Medical Co., Ltd., November 2013 to May 2014). Fifty-three facilities in Japan participated in these two trials. In order to share the procedure, we posted the standard methods of SEMS placement on the website, based on previously published data. As for BTS, patients were followed until discharge after surgery. Clinical success in a BTS was defined as the adequate passage of stool after stenting until surgery, without any stent-related complications and the need for endoscopic re-intervention or emergency surgery.
RESULTS: A total of 718 consecutive patients were enrolled. Eleven patients were excluded and the remaining 709 patients were evaluated as a per-protocol cohort. We performed colonic stenting as BTS for malignant colorectal obstruction in 424 (312 in WallFlex and 112 in Niti-S) patients. Technical success rate was 98.1% (416/424). Clinical success rate was 91.7% (389/424). SEMS-related preoperative complications occurred in 6.4% (27/424) of total, 7.1% (22/312) of WallFlex, and 4.5% (5/112) of Niti-S patients. Perforations occurred in 1.2% (5/424) of total, 1.6% (5/312) of WallFlex, and 0% (0/112) of Niti-S patients. Stent migration occurred in 1.2% (5/424) of total, 1.3% (4/312) of WallFlex, and 0.9% (1/112) of Niti-S patients. Open and laparoscopic surgeries were performed in 158 (39%) and 250 patients (61%), respectively. The conversion rate from laparoscopic to open surgery was 10.4% (26/250). Tumors were resected in 94.3% (400) of patients, and primary anastomosis was possible in 95.8% (383/400). Anastomosis leakage occurred in 3.9% of those patients (15/383). The stoma creation rate was 8.4% (35/407). Overall rate of postoperative complications was 17.3% (72/416), and the mortality rate was 0.4% (2/415). The median hospital stay was 12 days (range, 4–114 days).
CONCLUSION: SEMS placement was an effective BTS treatment for patients with malignant colorectal obstruction. It was a safe intervention with acceptable stoma creation and complication rate. Sharing clinical experience and methods of SEMS placement on the website will improve the safety and efficacy of SEMS.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 77750
Program Number: S046
Presentation Session: Colorectal 1
Presentation Type: Podium