Sclerotherapy-associated esophageal ulcers: lessons from a double-blind, randomized comparison of sucralfate suspension versus placebo.

We undertook a double-blind randomized trial to assess whether sucralfate suspension would accelerate healing of sclerotherapy-associated esophageal ulcers. Consecutive patients who underwent sclerotherapy were evaluated. Patients were prospectively endoscoped 4 days (range, 3 to 5 days) after sclerotherapy. Those with ulcers greater than 5 mm in diameter were randomized to receive sucralfate suspension, 4 g/day (10 ml four times a day), or placebo. Endoscopic evaluations were done weekly for the 4 weeks of therapy. Nineteen patients survived long enough to be evaluated; complete ulcer healing was scored as success. Nine patients (13 ulcers) received sucralfate and 10 patients (17 ulcers) received placebo. At the end of 4 weeks, 78% of ulcers in sucralfate-treated patients had healed compared with 40% in the placebo group (p = not significant). Large ulcers were found to heal more slowly (p = 0.03, life table analysis) and small ulcers were disproportionally represented in patients receiving sucralfate (67% compared with 40% in the placebo group). When ulcer size was taken into account, the possible drug advantage disappeared; ulcer size appears to be a major determinant of rate of healing of sclerotherapy-associated esophageal ulcers. A large multicenter trial will be required to identify whether sucralfate accelerates postsclerotherapy esophageal ulcer healing.

RCT Entities:   Population Interventions Outcomes