Endoscopic balloon dilation with steroid injection versus radial incision and cutting with steroid injection for refractory esophageal anastomotic stricture: a randomized study

Background Esophageal stricture causes severe distress to patients. However, there are no established treatments for refractory esophageal anastomotic stricture to endoscopic balloon dilation (EBD). Steroid injection added to EBD and radial incision and cutting (RIC) are effective for such strictures, but it is unclear which is more effective. The objective of this study was to investigate the safety and efficacy of RIC with steroid injection compared to EBD with steroid injection for patients with refractory anastomotic stricture after esophagectomy. Methods This was a multicenter, randomized phase II/III trial. Patients with refractory esophageal anastomotic strictures to three dilations or more were eligible. The primary endpoint in phase II part was proportion of Grade 3/4 predefined adverse events. Co-primary endpoints in phase III part were re-stricture-free survival and number of EBDs in the 24 weeks after treatment. Results One hundred and thirty patients were enrolled. Dysphagia score represented grade 2 in 104 patients (80·0%). The median number of dilations before registration was five in each arm. Grade 3/4 predefined adverse events occurred in two patients (3·1%) in each arm. Re-stricture-free survival was 10·6 weeks (95% confidence interval (CI): 6·9-20·1 weeks) and 8.7 weeks (95% CI: 7·1-10·9 weeks) in EBD and RIC, respectively (one-sided P=0·82). The median number of EBDs for 24 weeks after initial treatment was one (IQR: 0-2) in EBD and two (IQR: 0-3) in RIC (one-sided P=0·99). Conclusions EBD combined with steroid injection is the standard treatment for refractory anastomotic stricture after esophagectomy.