NCT01000779

Comparison of Endoscopic Variceal Ligation (EVL) With Propranolol in Non Cirrhotic Portal Hypertension (NCPH)

Comparison of Endoscopic Variceal Ligation (EVL) and Propranolol in Secondary Prophylaxis of Variceal Bleeding in Patients With Non Cirrhotic Portal Hypertension (NCPH): A Prospective Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Govind Ballabh Pant Hospital · Other Government
• Sex: All
• Age: 2 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Background: Variceal bleeding is a major cause of morbidity and mortality in patients with Non Cirrhotic Portal Hypertension (NCPH). Beta blockers (BB) and endoscopic variceal ligation (EVL) have been used to prevent rebleeding in these patients, largely based on data from cirrhotic patients. Endotherapy in the form of EST has been well studied in preventing rebleed in patients with NCPH. Initial studies showed that EST significantly reduced the rebleeding rate in patients of NCPH. Data from these studies suggests a rebleed rate of approximately 25% at 2yr and 35% at 5 years. Beta blockers have been found to be quite effective in both primary as well as secondary prophylaxis of variceal bleeding in cirrhotic and are accepted mode of treatment. In contrast to liver cirrhosis, published data on the effect of beta blocker therapy on NCPH are scanty. Animal data and human data suggests that beta blockers reduce portal pressure in patients with NCPH. In two placebo controlled trials of propranolol on secondary prophylaxis of variceal bleeding in non cirrhotic patients. both studies demonstrated the efficacy of propranolol in decreasing rebleed rate. However, no comparisons hae been made with EVL till date. Hypothesis: The investigators hypothesis that In patients with NCPH, treatment with beta blockers will lead to reduction in portal pressure and decrease in portosystemic shunting leading to reduction in variceal rebleeding Aim of the study: Aim: To compare the efficacy and safety of Propranolol and EVL in the prevention of variceal rebleeding in patients with NCPH.

Conditions

• Non Cirrhotic Portal Hypertension

Interventions

Type	Name	Description
DRUG	Propranolol	upto 320mg/day maximum
DEVICE	multi band ligator for esophageal varices	to obliterate esophageal varices

Timeline

• Start date: 2005-01-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2009-10-23
• Last updated: 2010-12-22

Locations

1 site across 1 country: India