Randomized trial comparing esophageal resection versus substitution alone for corrosive esophageal strictures.

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 < 0.001). However, total operative duration, blood loss, cervical anastomotic leak rates, recurrent laryngeal nerve palsy, and length of hospital stay were comparable between groups. One mortality (0.7%) occurred in the resection group due to a colo-colic anastomotic leak. At 12-months, mean GIQLI scores were higher following resection (118.6 ± 11.2 vs. 111.2 ± 12.8; p=0.08).

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).