Esophageal Self-Dilation in Benign Refractory Esophageal Strictures: Outcomes from a Randomized Controlled Trial and a Prospective Observational Study.

ABSTRACT

BACKGROUND: Patients with benign esophageal strictures may not maintain a response to endoscopic dilation, stenting, incisional or injectional therapies. For patients with these refractory esophageal strictures, esophageal self-dilation therapy (ESDT), performed to maintain luminal patency, may provide persistent symptomatic benefit while reducing patients' reliance on healthcare services and the risk associated with repeated endoscopic procedures. AIMS: The aim of this study was to evaluate the efficacy and safety of EDST in a randomized controlled trial and prospective observational study. METHODS: Twenty-five patients with refractory benign esophageal strictures were recruited at two esophageal clinics between November 2018 and June 2021. Twelve patients participated in the randomized trial and 13 in the prospective observational study. The number of endoscopic dilations, impact of therapy on dysphagia, adverse events, and complications were recorded. RESULTS: In the randomized study, 50% of patients performing ESDT and 100% of controls required endoscopic dilation during follow-up (P = 0.02). In the observational study, the median (IQR) number of endoscopic dilations fell from 7 [7-10] in the 6 months prior to commencing ESDT to 1 [0-2] in the 6 months after (P < 0.0001). Most patients (22/25) were able to learn self-dilation. Few serious adverse events were noted. Dysphagia severity remained unchanged or improved. CONCLUSIONS: ESDT appears to be a safe effective therapy for benign esophageal strictures refractory to endoscopic treatment. CLINICAL TRIAL NUMBER NCT03738566.