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

NCT01000779 | Completed Phase 3 DMC

• 1 other identifier: NG001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Cirrhotic Portal Hypertension

Keywords

Non Cirrhotic Portal Hypertension, secondary prophylaxis

Outcome Measures

Primary Outcomes (1)

• Rebleed, death

  At least 3 months after last enrollment

Secondary Outcomes (1)

• 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

Study Arms (2)

Endoscopic Variceal Ligation

ACTIVE COMPARATOR

endoscopic therapy to obliterate varices

Device: multi band ligator for esophageal varices

Propranolol

ACTIVE COMPARATOR

drugs to decrease portal pressure

Drug: Propranolol

Interventions

Propranolol DRUG

upto 320mg/day maximum

Propranolol

multi band ligator for esophageal varices DEVICE

to obliterate esophageal varices

Endoscopic Variceal Ligation

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Govind Ballabh Pant Hospital: lead

Study Sites (1)

Department of Gastroenterology, GB Pant Hospital,

New Delhi, National Capital Territory of Delhi, 110002, India

Location

Related Publications (1)

• Sarin SK, Gupta N, Jha SK, Agrawal A, Mishra SR, Sharma BC, Kumar A. Equal efficacy of endoscopic variceal ligation and propranolol in preventing variceal bleeding in patients with noncirrhotic portal hypertension. Gastroenterology. 2010 Oct;139(4):1238-45. doi: 10.1053/j.gastro.2010.06.017. Epub 2010 Jun 12.

  PMID: 20547163 DERIVED

MeSH Terms

Interventions

Propranolol

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Shiv K Sarin, MD, DM

  G.B. Pant Hospital, New Delhi, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 23, 2009
• Study Start: January 1, 2005
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 22, 2010

Record last verified: 2009-10

Locations

IN (1)