Rigid versus fiberoptic endoscopic injection sclerotherapy. A prospective randomized controlled trial in patients with bleeding esophageal varices.

During a 3-year period (June 1981-July 1984), 70 patients who presented with an endoscopically proven variceal bleed were randomized to receive either fiberoptic injection sclerotherapy (FIS, 36 patients) or a rigid scope technique (RIS, 34 patients), using ethanolamine oleate as the sclerosing agent. After discharge, patients entered into a chronic injection sclerotherapy program. Control of the acute bleeding episode (FIS, 91%, RIS, 95%) and the first hospital admission mortality (FIS, 34%, RIS, 44%) were similar. Eradication of varices was achieved in 16/19 and 13/16 cases in the two respective groups of patients who survived longer than 3 months, and only 2 of these patients (both of whom were in the RIS group) had a further major variceal bleed. The overall complication rate per injection was significantly lower in the FIS group (p less than 0.005). Twenty-six patients (14 FIS, 12 RIS) were alive at the end of the 4-year trial period. Of the total of 44 deaths, only 3 were not associated with a bleeding episode. Only five of the 29 patients who had their varices eradicated died during the trial period (median follow-up of 16 months). FIS has become the preferred method of treatment at the Groote Shuur Hospital, particularly in the long-term management of these patients. The procedure is safe, does not require a general anesthetic, and in long-term management, most patients can be treated on an outpatient basis. RIS should be reserved for the difficult recurrent acute bleeder, where the more controlled situation with a rigid scope under general anesthesia may provide safer and more effective sclerotherapy. The study stresses the importance of achieving eradication of all varices to prevent rebleeding and its attendant high mortality.

RCT Entities:   Population Interventions Outcomes