NCT01000779

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

Completed Phase 3 Last updated 21 December 2010

What this trial tests

Phase 3 trial testing Propranolol in Non Cirrhotic Portal Hypertension in 100 participants. Completed in 1 October 2009.

Timeline

1 January 2005

Primary endpoint
1 October 2009

1 October 2009

Quick facts

Lead sponsor	Govind Ballabh Pant Hospital
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	100
Start date	1 January 2005
Primary completion	1 October 2009
Estimated completion	1 October 2009
Sites	1 location across India

Drugs / interventions tested

• Propranolol (propranolol) — full drug profile →
• multi band ligator for esophageal varices

Conditions studied

• Non Cirrhotic Portal Hypertension — all drugs for Non Cirrhotic Portal Hypertension →

Sponsor

Govind Ballabh Pant Hospital

Who can join

Adults 2 to 75, any sex, with Non Cirrhotic Portal Hypertension. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Rebleed, death
  Time frame: At least 3 months after last enrollment

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.