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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



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.

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This study was conducted with Japan Gastroenterological Endoscopy Society funding support and the Colonic Stent Safe Procedure Research Group membership dues.

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Corresponding author

Correspondence to Shuji Saito.

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Dr. Shuji Saito has received personal fees from Boston Scientific Japan, Century Medical Inc; Dr. Shuntaro Yoshida has received personal fees from Boston Scientific Japan, Century Medical Inc and ZEON Co, Dr. Hiroyuki Isayama has received donations and personal fees from Boston Scientific Japan, Century Medical Inc and Taewoong Medical Devices Inc. Drs. Takeaki Matsuzawa, Toshio Kuwai, and Mamoru Shimada have received personal fees from Boston Scientific Japan; Dr. Iruru Maetani has received personal fees from Boston Scientific Japan, Century Medical Inc, Piolax Medical Device Inc, and MC Medical Inc; Dr. Koichi Koizumi has received personal fees from Century Medical Inc and Olympus Medical Systems Corp; and Dr. Yoshihisa Saida has received grants and personal fees from Boston Scientific Japan, Century Medical Inc, and Olympus Medical Systems Corp. Drs. Tomonori Yamada, Masafumi Tomita, Nobuto Hirata, Hideki Kanazawa, Toshiyuki Enomoto, and Hitoshi Sekido have no conflicts of interest or financial ties to disclose.



The Colonic Stent Safe Procedure Research Group includes the following members in addition to the authors.

Tatsuya Osuga, Aijinkai Takatsuki General Hospital, Takatsuki, Japan; Masaki Kikkawa, Akita Red Cross Hospital, Akita, Japan; Mitsuru Goto, Asahikawa Kosei Hospital, Asahikawa, Japan; Shungo Endo, Fukushima Medical University Aizu Medical Center, Aizu-wakamatsu, Japan; Sayo Kobayashi, Fukuyama City Hospital, Fukuyama, Japan; Shigeru Yamagishi, Fujisawa City Hospital, Fujisawa, Japan; Ken Konishi, Higashiosaka City General Hospital, Higashiosaka, Japan; Masanori Yoshimitsu, Hiroshima City Asa Hospital, Hiroshima, Japan; Satoshi Ikeda, Hiroshima Prefectural Hospital, Hiroshima, Japan; Rintaro Moroi, Iwate Prefectural Isawa Hospital, Oshu, Japan; Michiaki Watanabe, Kawaguchi Municipal Medical Center, Kawaguchi, Japan; Hirofumi Kawamoto, Kawasaki Medical School, Okayama, Japan; Hirotoshi Hasegawa, Keio University School of Medicine, Tokyo, Japan; Atsushi Yamauchi, Kitano Hospital, Osaka, Japan; Fuminori Teraishi, Kochi Health Sciences Center, Kochi, Japan; Kohei Takayasu, Kyorin University Hospital, Mitaka, Japan; Takahiro Horimatsu, Kyoto University Hospital, Kyoto, Japan; Yoshinori Kushiyama, Matsue Red Cross Hospital, Matsue, Japan; Hiroaki Naota, Matsusaka Chuo General Hospital, Matsusaka, Japan; Takuya Yamaguchi, Mimihara General Hospital, Sakai, Japan; Shigenori Masaki, Miyanomori Memorial Hospital, Sapporo, Japan; Taku Sakamoto, National Cancer Center Hospital, Tokyo, Japan; Kazuhiro Watanabe, National Center for Global Health and Medicine, Tokyo, Japan; Masafumi Inomata, Oita University Faculty of Medicine, Oita, Japan; Nobuya Obana, Osaki Citizen Hospital, Osaki, Japan; Masayoshi Horimoto, Osaka Saiseikai Senri Hospital, Suita, Japan; Rika Kyo, Saiseikai Yokohamashi-Nanbu Hospital,Yokohama, Japan; Shinei Kudo, Showa University Northern Yokohama Hospital, Yokohama, Japan; Yasushi Nakamura, Takano Hospital, Kumamoto, Japan; Mitsunori Ushigome, Toho University Omori Medical Center, Tokyo, Japan; Takeshi Ohki, Tokyo Women’s Medical University, Tokyo, Japan; Hiroyuki Kato, Tokyo Women’s Medical University Medical Center East, Tokyo, Japan; Shiro Hayashi, Toyonaka Municipal Hospital, Toyonaka, Japan; Tomio Hirakawa, Yao Tokushukai General Hospital, Yao, Japan; and Kensuke Kubota, Yokohama City University Hospital, Yokohama, Japan.

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Saito, S., Yoshida, S., Isayama, H. et al. 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. Surg Endosc 30, 3976–3986 (2016).

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  • Colon and rectal cancer
  • Intestinal obstruction
  • Self-expandable metallic stent
  • Bridge to surgery
  • Multicenter study
  • Prospective cohort study