Status:
COMPLETED
Comparison of Endoscopic Variceal Ligation (EVL) With Propranolol in Non Cirrhotic Portal Hypertension (NCPH)
Lead Sponsor:
Govind Ballabh Pant Hospital
Conditions:
Non Cirrhotic Portal Hypertension
Eligibility:
All Genders
2-75 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01000779
Start Date
January 1 2005
End Date
October 1 2009
Last Update
December 22 2010
Active Locations (1)
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1
Department of Gastroenterology, GB Pant Hospital,
New Delhi, National Capital Territory of Delhi, India, 110002