A prospective controlled trial of sclerotherapy in the long term management of patients after esophageal variceal bleeding.

The preliminary results of the first 25 months of a prospective randomized controlled clinical trial, designed to compare repeated injection sclerotherapy with conservative medical management in the long term treatment of all patients shown to have previously bled from esophageal varices, are presented in detail. To date, 31 patients have been randomized, 15 in the chronic injection group and 16 in the control medical management group. In addition, five patients excluded for geographic reasons have been injected out of trial. Ethanolamine oleate has been injected into the varices, using a modified rigid esophagoscope under general anesthesia. The preliminary results have been encouraging. It has been possible to eradicate esophageal varices in the chronic injection group and, once the varices had been eradicated, no patient had recurrence of variceal bleeding. On the other hand, recurrent variceal bleeds have remained a continuing problem in a number of the patients in the control study. A longer follow-up period will be required to assess both the quantitative and the qualitative aspects of survival and to determine how long esophageal varices will remain eradicated as well as how frequently repeated injections will be required.

RCT Entities:   Population Interventions Outcomes