A randomized controlled trial of β-blockers versus endoscopic band ligation for primary prophylaxis

A large sample size is required to show a difference in bleeding rates

Paul J. Thuluvath, Anurag Maheshwari, Sanjay Jagannath, Aravind Arepally

Research output: Contribution to journalArticle

Abstract

Primary prophylaxis with nonselective β-blockers in high-risk subjects has been shown to be effective in reducing both esophageal variceal bleeding and mortality. Recently it has been suggested that band ligation may be a better option for primary prophylaxis. We compared nonselective β-blockers with band ligation in patients with large varices (F2, F3) and elevated hepatic venous wedge pressure gradient (HVWPG, ≥12 mm Hg). All patients were prospectively followed for variceal bleeding, mortality, and treatment-related complications. Based on previous published studies, we estimated that 90 patients in each arm would be required to show a difference in bleeding rate. The study was prematurely terminated when we realized that our estimated sample size was inadequate to show a difference based on the observed bleeding rate. At the time of termination, 31 patients (Child A, 11; B, 14; C, 6), with a mean HVWPG of 19 ± 9.1 mm Hg, were randomized to either band ligation (group A; n = 16) or β-blockers (group B; n = 15). Baseline demographics of both groups were similar and the mean follow-up period was 27.4 ± 12.9 months. During the follow-up, two patients in group A and one patient in group B had bleeding. Nine patients (29%; group A, six; group B, three; P = ns) died due to non-bleeding-related causes and five (16%) patients (group A, three; group B, two) underwent liver transplantation. Treatment-related complication were minimal in both groups. Despite the selection of high-risk patients, the observed bleeding rate was much lower than anticipated. Based on our observed bleeding rates, 424 patients would be required in each arm to show a difference between band ligation and β-blocker therapy.

Original languageEnglish (US)
Pages (from-to)407-410
Number of pages4
JournalDigestive Diseases and Sciences
Volume50
Issue number2
DOIs
StatePublished - Feb 2005

Fingerprint

Sample Size
Ligation
Randomized Controlled Trials
Hemorrhage
Pulmonary Wedge Pressure
Venous Pressure
Mortality
Varicose Veins
Liver Transplantation
Therapeutics
Demography
Liver

Keywords

  • β-blockers
  • Banding
  • Cirrhosis
  • Esophageal varices

ASJC Scopus subject areas

  • Gastroenterology

Cite this

A randomized controlled trial of β-blockers versus endoscopic band ligation for primary prophylaxis : A large sample size is required to show a difference in bleeding rates. / Thuluvath, Paul J.; Maheshwari, Anurag; Jagannath, Sanjay; Arepally, Aravind.

In: Digestive Diseases and Sciences, Vol. 50, No. 2, 02.2005, p. 407-410.

Research output: Contribution to journalArticle

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