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

Eur J Gastroenterol Hepatol. 1996 Apr;8(4):337-42. doi: 10.1097/00042737-199604000-00010.


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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Disease-Free Survival
  • Esophageal and Gastric Varices / mortality
  • Esophageal and Gastric Varices / therapy*
  • Female
  • Follow-Up Studies
  • Gastrointestinal Hemorrhage / mortality
  • Gastrointestinal Hemorrhage / prevention & control*
  • Hemostasis, Endoscopic* / adverse effects
  • Humans
  • Hypertension, Portal / complications
  • Ligation / adverse effects
  • Ligation / methods
  • Male
  • Recurrence
  • Risk Factors
  • Time Factors