Prophylactic banding ligation of high-risk esophageal varices in patients with cirrhosis: a prospective, randomized trial

Abstract

Background/aims: Injection sclerotherapy has been used to prevent the first episode of variceal hemorrhage, but the results are controversial. The value of banding ligation in the prophylaxis of the first episode of variceal bleeding has not yet been completely evaluated. This study was conducted to determine whether prophylactic banding ligation is beneficial for cirrhotic patients with high-risk esophageal varices.

Methods: A total of 127 cirrhotic patients with endoscopically-assessed high-risk esophageal varices but no history of bleeding were randomized to undergo banding ligation (64 patients) or to serve as controls (63 patients). Ligation was performed at 3-week intervals until variceal obliteration was obtained.

Results: During a median follow-up of 29 months, 14 patients (21.8%) in the ligation group and 22 patients (34.9%) in the control group experienced upper gastrointestinal bleeding (p = 0.15). Variceal bleeding occurred in eight patients (12.5%) in the ligation group and 14 patients (22.2%) in the control group (p = 0.22). Blood transfusion requirements were fewer in the EVL group than in the control group (0.6+/-0.4 units vs. 1.2+/-0.8 units, p<0.001). Furthermore, variceal bleeding was significantly reduced in Child-Pugh class B patients treated with ligation compared with the control group (p<0.05). Sixteen patients (25%) in the ligation group and 23 patients (36.5%) in the control group died. Comparison of Kaplan-Meier estimates of time to death for the two groups did not show significant differences (p = 0.19). More patients died of uncontrollable variceal bleeding in the control group (7 patients, 11%) than in the ligation group (3 patients, 4.7%) (p = 0.15).

Conclusions: Although prophylactic ligation did not significantly reduce the first episode of bleeding from esophageal varices in cirrhotic patients with high-risk esophageal varices, a subgroup of patients (Child-Pugh class B) had a reduced frequency of the first episode of esophageal variceal bleeding after prophylactic banding ligation. Furthermore, there was a trend of reducing mortality from variceal bleeding in patients receiving prophylactic ligation. Prophylactic ligation is a promising treatment, but requires further investigation.