Endoscopic esophageal probe dilation followed by intralesional compound betamethasone injection for anastomotic strictures after esophagectomy: a randomized controlled trial / 中华胸心血管外科杂志

ABSTRACT

Objective:To assess the efficacy, safety of adding intralesional compound betamethasone injection to EEBD to reduce restricture.Methods:77 patients, treated in The first people's hospital of YancHeng from January, 2015 to December, 2018, were randomized to receive EEPD combined with either compound betamethasone injection or placebo injection. A total of 2 ml of compound betamethasone injection or an identical volume of normal saline solution as a placebo was injected per site using a 23-gauge needle immediately after EEPD. Patients and treating physicians were blinded to the treatment. The primary endpoint was the number of dilations required to resolve the stricture、restricture-free survival、time required to resolve the stricture and adverse events.Results:During the 4-years study period, Finally , 74 patients , who were randomized to either the steroid group (37 cases) or placebo group (37 cases), comprised the per-protocol population .The median number of EEPD required to resolve strictures was 2.0( IQR 1.0-3.0) in the steroid group and 3.0 ( IQR 3.0-4.5) in the placebo group ( P<0.001). After 6 months of follow-up, 27.0% of patients who had received steroid injections remained recurrence free compared with 3.5% of those who had received saline injections( P<0.001). The median time of EEPD required to resolve the stricture was 88 days( IQR 0-98 days)in the steroid group and 131 days( IQR 97-157 days)in the placebo group( P<0.001). No adverse events occurred related to the EEPD or steroid injection occurred. Conclusion:Endoscopic esophageal probe dilation combined with compound betamethasone injection shows promising results for the prevention of stricture recurrence in patients of anastomotic strictures.