title: A randomized controlled Phase II/III study comparing endoscopic balloon dilation combined with steroid injection versus radial incision and cutting combined with steroid injection for refractory anastomotic stricture after esophagectomy: Japan Clinical Oncology Group Study JCOG1207.
abstract: A randomized Phase II/III trial commenced in May 2014. Endoscopic balloon dilation with steroid injection is the current standard treatment for patients with refractory anastomotic stricture after esophagectomy. The purpose of this study is to confirm the superiority of radial incision and cutting with steroid injection in terms of both restricture-free survival and number of dilations within 24 weeks compared with endoscopic balloon dilation with steroid injection for these patients. A total of 130 patients will be accrued from 30 Japanese institutions over 3 years. The primary endpoint in the Phase II part is proportion of Grade 3/4 intraoperative hemorrhages, post-operative esophageal perforations, esophageal hemorrhages, pneumothorax, lung or mediastinum infections or other unexpected adverse events. Co-primary endpoints in the Phase III part are restricture-free survival and number of dilations within 24 weeks after treatment. Secondary endpoints are proportion of patients with anastomotic diameter >10 mm at 8 weeks after treatment, proportion of adverse events, proportion of patients experiencing improvement of dysphagia score at 2, 4, 8 and 24 weeks after treatment and proportion of patients with dysphagia score ≤1 at 24 weeks after treatment. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000014017 [http://www.umin.ac.jp/ctr/index.htm].
authors: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors: Kozo
authors: K
authors: Kataoka
authors: Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto.
authors: Ikuo
authors: I
authors: Aoyama
authors: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors: Junki
authors: J
authors: Mizusawa
authors: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors: Junko
authors: J
authors: Eba
authors: Clinical Trial Promotion Department, Chiba Cancer Center, Chiba.
authors: Keiko
authors: K
authors: Minashi
authors: Department of Gastroenterology, Endoscopy Division, National Cancer Center Hospital East, Chiba.
authors: Tomonori
authors: T
authors: Yano
authors: Endoscopy Division, Shizuoka Cancer Center, Shizuoka.
authors: Masaki
authors: M
authors: Tanaka
authors: Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors: Noboru
authors: N
authors: Hanaoka
authors: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors: Hiroshi
authors: H
authors: Katayama
authors: Endoscopy Division, Shizuoka Cancer Center, Shizuoka.
authors: Kohei
authors: K
authors: Takizawa
authors: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors: Haruhiko
authors: H
authors: Fukuda
authors: Manabu
authors: M
authors: Muto
mesh_terms: D003131:Combined Modality Therapy; D003251:Constriction, Pathologic / Q000209:etiology / Q000628:therapy; D003680:Deglutition Disorders / Q000209:etiology / Q000628:therapy; D004106:Dilatation / Q000295:instrumentation / Q000379:methods*; D016099:Endoscopy, Gastrointestinal / Q000379:methods*; D004938:Esophageal Neoplasms / Q000601:surgery; D004940:Esophageal Stenosis / Q000209:etiology / Q000628:therapy*; D016629:Esophagectomy / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007431:Intraoperative Complications; D007564:Japan; D008297:Male; D011183:Postoperative Complications; D013256:Steroids / Q000008:administration & dosage*
chemical_list: D013256:Steroids
keywords: anastomotic stricture; endoscopic balloon dilation (EBD); radial incision and cutting (RIC); steroid injection