A prospective randomized trial of sclerotherapy versus ligation in the elective treatment of bleeding esophageal varices

Abstract

Background and study aims: Endoscopic ligation (EVL) and endoscopic variceal sclerotherapy (EVS) are known to be equally effective in eradicating bleeding esophageal varices in patients with hepatic cirrhosis, but the long-term safety and efficacy of the two techniques have not been clearly established. The aim of this study was to determine the relative frequency of rebleeding, recurrence of varices, and survival after treatment with the two techniques during a relatively long follow-up period.

Patients and methods: A total of 111 patients without bleeding at the index endoscopy were randomly assigned to either EVL (n = 57) or EVS (n = 54). After eradication of the varices, the patients received endoscopic examinations every three months and for each episode of rebleeding.

Results: The mean follow-up periods were 534 +/- 42 days in the EVS group and 496 +/- 40 days in the EVL group. The two techniques were equally effective in eradicating varices (93% in EVL group and 92.5% in EVS group). The mean number of sessions required to obtain eradication was slightly lower (mean +/- SE) in the EVL group (3.5 +/- 0.1 vs. 4.0 +/- 0.1, P = 0.004), while the time required for eradication was longer (33.8 +/- 2.1 vs. 27.3 +/- 1.4, P = 0.01). The comparison of the Kaplan-Meier estimates of survival and time to first rebleeding did not show any statistically significant differences between the two groups. The rate of complications was significantly higher in the EVS group than in the EVL group (31% vs. 11%, P = 0.001), while the rate of recurrent varices during follow-up was higher in the EVL group (30% vs. 13%, P = 0.03).

Conclusions: While the two techniques are equally effective, ligation treatment shows greater advantages in the short-term follow-up, but is associated with more frequent recurrence of varices in the longer term. These two aspects should be considered for evaluation in the cost-benefit ratio and quality of life analysis. All patients should have frequent endoscopic evaluations (every three or four months) throughout the first year of follow-up.