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

This study has been completed.
Sponsor:
Information provided by:
Govind Ballabh Pant Hospital
ClinicalTrials.gov Identifier:
NCT01000779
First received: October 22, 2009
Last updated: December 21, 2010
Last verified: October 2009
  Purpose

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 Intervention Phase
Non Cirrhotic Portal Hypertension
Drug: Propranolol
Device: multi band ligator for esophageal varices
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Govind Ballabh Pant Hospital:

Primary Outcome Measures:
  • Rebleed, death [ Time Frame: At least 3 months after last enrollment ] [ Designated as safety issue: No ]

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 [ Time Frame: At least 3 months after last enrollment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2005
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000779

Locations
India
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
  More Information

No publications provided by Govind Ballabh Pant Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shiv K Sarin, G.B. Pant Hospital, New Delhi, India
ClinicalTrials.gov Identifier: NCT01000779     History of Changes
Other Study ID Numbers: NG001
Study First Received: October 22, 2009
Last Updated: December 21, 2010
Health Authority: India: Drugs Controller General of India

Keywords provided by Govind Ballabh Pant Hospital:
Non Cirrhotic Portal Hypertension, secondary prophylaxis

Additional relevant MeSH terms:
Hypertension
Hypertension, Portal
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Propranolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents

ClinicalTrials.gov processed this record on April 15, 2014