Abstract
Objective
To compare perioperative safety and long-term functional outcomes of esophageal resection versus substitution-alone in patients with corrosive esophageal strictures refractory to endoscopic dilatation.Methods
This prospective, single-center, open-label, parallel-group, non-inferiority randomized controlled trial was conducted at a tertiary referral center in India. Patients aged 14-60 years with corrosive esophageal strictures unresponsive to serial dilatation were included. Participants were randomized in a 1:1 ratio to either esophageal resection or substitution-alone group. The primary outcome was incidence of postoperative pulmonary complications (PPC) within 30 days. Secondary outcomes included operative parameters, postoperative morbidity, mortality, and health-related quality-of-life (HRQOL) assessed using the Gastrointestinal-Quality-of-Life-Index (GIQLI).Results
Between September 2012 and December 2023, 143 patients were randomized (resection, n=69; substitution-alone, n=74), and all were analyzed. PPC occurred in 11.6% of the resection group and 8.1% of the substitution-alone group (absolute risk difference, 3.5%; 95% CI -6.3% to 13.3%); the prespecified non-inferiority criterion was not met. Mediastinal dissection time was significantly longer in the resection group (48 ± 28 vs 22 ± 8 min; p Conclusions
Esophageal resection and substitution-alone were associated with comparable perioperative outcomes in patients with corrosive esophageal strictures. Although formal non-inferiority of esophageal resection was not established, no significant difference in PPC was observed. The higher HRQOL scores following resection should be considered exploratory.Trial registration
Clinical Trials Registry of India (CTRI/2015/10/006237).