Comparison of Endoscopic Variceal Ligation (EVL) With Propranolol in Non Cirrhotic Portal Hypertension (NCPH)
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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 |
- Rebleed, death [ Time Frame: At least 3 months after last enrollment ] [ Designated as safety issue: No ]
- 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 |
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| India | |
| Department of Gastroenterology, GB Pant Hospital, | |
| New Delhi, Delhi, India, 110002 | |
| 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 June 17, 2013