A randomized controlled trial of endoscopie variceal band ligation for primary prophylaxis of variceal bleeding

OBJECTIVE: To assess the efficacy and safety of endoscopic variceal band ligation (EVL) for primary prophylaxis of variceal bleeding in patients with high-risk varices. DESIGN: A randomized, controlled trial. SETTING: Hospital based. SUBJECTS: Sixty-eight patients with portal hypertension with high-risk varices were randomized to undergo either EVL (n = 35) or no treatment (n = 33). INTERVENTIONS: Endoscopic variceal band ligation or no therapy. MAIN OUTCOME MEASURES: Probability of first variceal bleeding, probability of survival, variceal obliteration, complications of EVL. RESULTS: Oesophageal varices could be obliterated by EVL in 3.2 +/- 1.2 sessions within 4.9 +/- 2.2 weeks. Three (8.6%) patients in the EVL group and 13 (39.4%) in the control group bled during a mean follow-up of 14.1 +/- 5.0 months (range 2-22) (P < 0.01). The cumulative probability of the patients remaining free of bleeding was higher (P < 0.01) in the EVL group than the control. Variceal recurrence was seen in 10 (28.6%) patients and was managed by repeated EVL. None of the patients developed oesophageal stricture. Four (11.4%) patients in the EVL and eight (24.2%) in the control group died (P = NS). Bleed-related mortality was lower in the EVL than the control group (2.9% vs. 15.2%, P = 0.08). CONCLUSION: EVL significantly decreases the frequency of first variceal bleed. It should be evaluated further to see if bleeding-related mortality could be reduced in cirrhotics with high-risk varices who have not bled.