Randomized trial of intralesional steroid injection versus oral prednisolone for preventing esophageal stricture after extensive endoscopic submucosal dissection

Summary Endoscopic submucosal dissection (ESD) is the preferred treatment for early esophageal neoplasms. However, ESD involving more than three-quarters of the esophageal circumference often leads to stricture formation. While corticosteroids are widely used to prevent strictures, the optimal route of administration remains unclear. This study aimed to compare submucosal corticosteroid injection (IC) with oral corticosteroid administration (OC) in decreasing the number of dilations required for stricture resolution, stricture rate, and stricture resolution rate. This was a single-center, open-label, randomized clinical trial. Thirty patients with esophageal mucosal defects involving more than three-quarters of the esophageal circumference were enrolled and randomly assigned to two groups. The IC group received 100 mg of triamcinolone injected into the resection bed immediately after the procedure. The OC group was given oral prednisolone starting 3 days post-ESD, initially at 30 mg/day, tapered over 8 weeks. A total of 30 patients were included, 15 in each group. The OC group required significantly fewer dilation sessions than the IC group (5 vs. 19; P = 0.04). However, the stricture rate was similar between the groups (OC: 66.7% vs. IC: 40%; P = 0.27), as well as the stricture resolution rate (OC: 50% vs. IC: 40%; P 0.99). No significant differences were observed in other adverse events or blood glucose levels between the groups. Oral corticosteroids resulted in fewer dilation sessions to resolve strictures after extensive esophageal ESD compared to intralesional injections. No differences were observed in stricture rates or other adverse events between the two groups. ClinicalTrials.gov (NCT04498260).