A randomized controlled trial of endoscopic 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.