A randomized controlled phase II/III study comparing EBD combined with steroid to RIC combined with steroid for refractory anastomotic stricture after esophagectomy (JCOG1207: RICS study)

INTERVENTION: A: EBD (endoscopic balloon dilation) followed by steroid (triamcinolone) injection to the dilated anastomotic stricture. Total amount of injected triamcinolone is 40mg/4ml. B: RIC (Radical Incision and Cutting) followed by steroid (triamcinolone) injection to the dilated anastomotic stricture. Total amount of injected triamcinolone is 40mg/4ml. CONDITION: Refractory anastomotic stricture after surgical resection for esophageal cancer PRIMARY OUTCOME: Phase II: Proportion of Grade 3/4 intraoperative hemorrhage, esophageal perforation or hemorrhage, pneumothorax, lung or mediastinum infection, or other unexpected adverse reactions. Phase III: Restenosis‐free survival; Number of dilation for 24 weeks after treatment SECONDARY OUTCOME: Phase II/III: Proportion of patients with anastomotic diameter > 10 mm at the time of 8 weeks after treatment; Proportion of adverse events; Proportion of patients experiencing improvement of dysphagia score at the time of 2, 4, 8, 24 weeks after treatment; Proportion of patients with dysphagia score <= 1 at the time of 24 weeks after treatment. INCLUSION CRITERIA: 1 st inclusion criteria 1) Meet all the following criteria about surgery for esophageal cancer: a) Subtotal esophagectomy for thoracic esophageal cancer performed. b) No finding of recurrence. c) Gastric tube reconstruction. d) No residual tumor. 2) Endoscopic balloon dilation (EBD) or bougienage for anastomotic stricture was performed more than twice for 24 weeks. If dilations were performed twice or more within 6 days , dilation was counted as once. 3) No prior history of endoscopic incision for anastomotic stricture. 4) Dysphagia score >=2. 5) Stricture length <=2cm diagnosed by endoscopy or X‐ray fluoroscopy. 6) No postoperative chemotherapy for esophageal cancer within 28 days before registration. 7) No prior history of radiotherapy for recurrence after esophagectomy or preoperative radiotherapy more than 60 Gy. 8) No prior history of chemotherapy for any cancer within 28 days before registration. 9) No plan of chem