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

Sponsor

Govind Ballabh Pant Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01000779

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non Cirrhotic Portal Hypertension	Drug: Propranolol Device: multi band ligator for esophageal varices	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Endoscopic Variceal Ligation endoscopic therapy to obliterate varices	Device: multi band ligator for esophageal varices to obliterate esophageal varices
Active Comparator: Propranolol drugs to decrease portal pressure	Drug: Propranolol upto 320mg/day maximum

Arm

Intervention/Treatment

Active Comparator: Endoscopic Variceal Ligation

endoscopic therapy to obliterate varices

Device: multi band ligator for esophageal varices

to obliterate esophageal varices

Active Comparator: Propranolol

drugs to decrease portal pressure

Drug: Propranolol

upto 320mg/day maximum

Outcome Measures

Primary Outcome Measures

Rebleed, death [At least 3 months after last enrollment]

Secondary Outcome Measures

Adverse effects of EVL or drug therapy, variceal eradication on EVL, variceal recurrence after eradication on EVL, decrease in variceal grade in the propranolol limb [At least 3 months after last enrollment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with Non Cirrhotic Portal Hypertension (NCPH) presenting to our Liver Diseases Follow-up Clinic with history of hemetemesis and/or malena within the past 6 weeks and proven to have esophageal varices as the bleeding source on upper GI endoscopy

Exclusion Criteria:

A history of surgery for portal hypertension
Patients already on a EST, EVL, or glue injection program before presenting to our hospital
Patients already on beta blockers for primary prophylaxis of variceal bleed
Severe cardiopulmonary or renal disease
Bradycardia (basal heart rate, <50 beats per minute [bpm]) or complete heart block
A history of severe side effects or contraindications to β- blockers, like bronchial asthma, diabetes mellitus, heart failure, peripheral vascular disease, prostatic hypertrophy, or arterial hypotension (systolic blood pressure <90 mm Hg)
Refusal to give informed written consent to participate in the trial
Patients bleeding from gastric varices or Portal Hypertensive Gastropathy (PHG).
Patients who had a failure of primary hemostasis during acute bleed were also excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gastroenterology, GB Pant Hospital,	New Delhi	Delhi	India	110002

Sponsors and Collaborators

Govind Ballabh Pant Hospital

Investigators

Principal Investigator: Shiv K Sarin, MD, DM, G.B. Pant Hospital, New Delhi, India

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01000779

Other Study ID Numbers:

NG001

First Posted:

Oct 23, 2009

Last Update Posted:

Dec 22, 2010

Last Verified:

Oct 1, 2009

Keywords provided by , ,

Non Cirrhotic Portal Hypertension, secondary prophylaxis

Additional relevant MeSH terms:

Hypertension, Portal

Hypertension

Propranolol

Study Results

No Results Posted as of Dec 22, 2010