Study protocol for a prospective, multicentre, phase II trial on endoscopic treatment using two fully covered self-expandable metallic stents for benign strictures after hepaticojejunostomy
Takuji Okusaka,
Shunsuke Kondo,
Chigusa Morizane,
Tetsuro Takasaki,
Hideki Ueno,
Yuki Kawasaki,
Susumu Hijioka,
Yoshikuni Nagashio,
Akihiro Ohba,
Yuta Maruki,
Kotaro Takeshita,
Shin Yagi,
Daiki Agarie,
Yuya Hagiwara,
Hidenobu Hara,
Kohei Okamoto,
Daiki Yamashige,
Souma Fukuda,
Masaru Kuwada
Affiliations
Takuji Okusaka
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Chuo-ku, Japan
Shunsuke Kondo
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Chuo-ku, Japan
Chigusa Morizane
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Chuo-ku, Japan
Tetsuro Takasaki
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Chuo-ku, Japan
Hideki Ueno
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Chuo-ku, Japan
Yuki Kawasaki
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Chuo-ku, Japan
Susumu Hijioka
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Chuo-ku, Japan
Yoshikuni Nagashio
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Chuo-ku, Japan
Akihiro Ohba
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Chuo-ku, Japan
Yuta Maruki
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Chuo-ku, Japan
Kotaro Takeshita
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Chuo-ku, Japan
Shin Yagi
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Chuo-ku, Japan
Daiki Agarie
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Chuo-ku, Japan
Yuya Hagiwara
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Chuo-ku, Japan
Hidenobu Hara
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Chuo-ku, Japan
Kohei Okamoto
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Chuo-ku, Japan
Daiki Yamashige
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Chuo-ku, Japan
Souma Fukuda
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Chuo-ku, Japan
Masaru Kuwada
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Chuo-ku, Japan
Introduction The current endoscopic treatment for postoperative benign hepaticojejunostomy anastomotic stricture (HJAS) has a high technical success rate and is highly effective in the short term. However, long-term results have shown a high rate of stenosis recurrence, which indicates an insufficient response to treatment. Three prospective studies on fully covered self-expandable metallic stent (FC-SEMS) treatment for benign HJAS used the stenosis resolution rate as the primary endpoint, and no study has yet used the long-term non-stenosis rate (at 12 months) as the primary endpoint.Methods and analysis We launched the ‘saddle-cross study’, which will be conducted as a multicentre, prospective intervention of endoscopic treatment using two modified FC-SEMSs (BONASTENT️ M-Intraductal) that have been improved for benign stenosis in patients with benign HJAS, with the long-term non-restenosis rate (at 12 months) as the primary endpoint. This study aims to evaluate the long-term non-restenosis rate (at 12 months) and safety of the saddle-cross technique for benign HJAS. We plan to enrol 50 participants.Ethics and dissemination This study has been approved by the Certified Review Board of the National Cancer Center, Japan (CRB3180009). The results will be reported at various conferences and published in international peer-reviewed journals.