Shuji Saito1, Shuntaro Yoshida2, Hiroyuki Isayama3, Takeaki Matsuzawa4, Toshio Kuwai5, Iruru Maetani6, Mamoru Shimada7, Tomonori Yamada8, Masafumi Tomita9, Koichi Koizumi10, Nobuto Hirata11, Hideki Kanazawa12, Toshiyuki Enomoto13, Hitoshi Sekido14, Yoshihisa Saida13. 1. 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. 2. Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan. 3. Department of Gastroenterology, Graduate School of Medicine, University of Tokyo, Tokyo, Japan. 4. Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Moroyama, Japan. 5. Department of Gastroenterology, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, Kure, Japan. 6. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Ohashi Medical Center, Tokyo, Japan. 7. Department of Surgery, Moriguchi Keijinkai Hospital, Moriguchi, Japan. 8. Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan. 9. Department of Surgery, Kishiwada Tokushukai Hospital, Kishiwada, 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 Surgery, National Hospital Organization Sagamihara Hospital, Sagamihara, Japan. 13. Department of Surgery, Toho University Ohashi Medical Center, Tokyo, Japan. 14. Department of Surgery, National Hospital Organization Yokohama Medical Center, Yokohama, Japan.
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.
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.
Entities:
Keywords:
Bridge to surgery; Colon and rectal cancer; Intestinal obstruction; Multicenter study; Prospective cohort study; Self-expandable metallic stent
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