Comparison of Endoscopic Variceal Ligation (EVL) With Propranolol in Non Cirrhotic Portal Hypertension (NCPH)
Information source: Govind Ballabh Pant Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non Cirrhotic Portal Hypertension
Intervention: Propranolol (Drug); multi band ligator for esophageal varices (Device)
Phase: Phase 3
Status: Completed
Sponsored by: Govind Ballabh Pant Hospital Official(s) and/or principal investigator(s): Shiv K Sarin, MD, DM, Principal Investigator, Affiliation: G.B. Pant Hospital, New Delhi, India
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Rebleed, death
Secondary outcome: 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
Eligibility
Minimum age: 2 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Department of Gastroenterology, GB Pant Hospital,, New Delhi, Delhi 110002, India
Additional Information
Starting date: January 2005
Last updated: December 21, 2010
|