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

Authors

Nihar Ranjan Dash, Lokesh Agarwal, Sujoy Pal, Alok Thakar, Chirom Amit Singh, Kumble Seetharama Madhusudhan, Saurav Sharma

Published in

Esophagus : official journal of the Japan Esophageal Society. Sep 20, 2026. Epub Sep 20, 2026.

Abstract

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.
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).
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).
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.
Clinical Trials Registry of India (CTRI/2015/10/006237).

PMID:
42763383
Bibliographic data and abstract were imported from PubMed on 20 Sep 2026.

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