Endoscopic esophageal probe dilation followed by intralesional compound betamethasone injection for anastomotic strictures after esophagectomy: a randomized controlled trial
10.3760/cma.j.cn112434-20200229-00079
- VernacularTitle:内镜下探条扩张联合复方倍他米松局部注射治疗食管癌术后吻合口狭窄的随机对照研究
- Author:
Zhonghua JIANG
1
;
Xiahong WANG
;
Jinling TANG
Author Information
1. 江苏省徐州医科大学盐城临床学院 盐城市第一人民医院消化科 224406
- Keywords:
Esophagectomy;
Anastomotic Strictures;
Endoscopic esophageal probe dilation;
Intralesional steroid injection
- From:
Chinese Journal of Thoracic and Cardiovascular Surgery
2021;37(6):367-371
- CountryChina
- Language:Chinese
-
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.
