Primary prophylaxis of variceal bleeding in cirrhotics unable to take beta-blockers: a randomized trial of ligation.

SUMMARY Aim: To compare endoscopic banding ligation vs. no treatment in cirrhotics with intolerance or contraindications to b-blockers for prevention of first bleeding in portal hypertension. Methods: A sample size of 214 was planned with all sizes of varices. However, the trial was stopped due to increased bleeding in 52 patients in the ligation group. The baseline severity liver disease and endoscopic features were similar. Ligation group: 25 (M/F ¼ 21/4, mean age: 60 ± 9.37 years); 27 not-treated group: 27 (M/F ¼ 17/10, mean age: 63 ± 10.27). Results: The mean follow-up period was 19.5 ± 13.3 months: five bled in the ligation group (20%), three from varices (two after banding at 11 and 17 days; one during the procedure), and two from gastropathy; two bled in the not-treated group (7% – two both varices) (P ¼ 0.24). There were seven deaths in the ligation group and 11 in the not-treated group (P ¼ 0.39). Conclusion: Sixty per cent of the bleeding in the banding group was probably iatrogenic, requiring the study to be stopped. Endoscopic banding ligation was no better than no treatment. This study suggests that ligation may be harmful when used as primary prophylaxis, similar to prophylactic sclerotherapy in the past.