Comparison of Endoscopic Variceal Ligation (EVL) With Propranolol in Non Cirrhotic Portal Hypertension (NCPH)
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|ClinicalTrials.gov Identifier: NCT01000779|
Recruitment Status : Completed
First Posted : October 23, 2009
Last Update Posted : December 22, 2010
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 or disease||Intervention/treatment||Phase|
|Non Cirrhotic Portal Hypertension||Drug: Propranolol Device: multi band ligator for esophageal varices||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||January 2005|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
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
upto 320mg/day maximum
- Rebleed, death [ Time Frame: At least 3 months after last enrollment ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000779
|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|