Status:
COMPLETED
Primary Prophylaxis of Gastric Varix Bleed
Lead Sponsor:
Govind Ballabh Pant Hospital
Conditions:
Cirrhosis
Eligibility:
All Genders
12-75 years
Phase:
NA
Brief Summary
In patients who have never bled from gastric varix (GOV2 and IGV1), cyanoacrylate injection will be better than both beta-blocker therapy and no treatment in prevention of gastric variceal bleed. The ...
Detailed Description
Patients are followed up every 3 months or at the time of end point or complications.
Eligibility Criteria
Inclusion
- Patients with GOV2 with eradicated esophageal varix or IGV1, who had never bled from gastric varix were included.
Exclusion
- Only esophageal varix, GOV1 with GOV2, acute bleed or past history of bleed from gastric varix, contraindications to beta-blocker therapy and cyanoacrylate injection.
- Prior injection of cyanoacrylate or sclerotherapy or variceal ligation or transjugular intrahepatic portosystemic shunt or balloon-occluded retrograde transvenous obliteration or balloon-occluded endoscopic injection sclerotherapy of gastric varix for prevention of bleeding from GV
- Patients already on beta-blocker or nitrates
- Undetermined origin of bleeding from esophageal varix or gastric varix
- Hepatic encephalopathy grade III/IV
- Hepatorenal syndrome
- Hepatocellular carcinoma
- Presence of deep jaundice (serum bilirubin \> 10 mg/dl)
- Uremia
- Cerebrovascular accident
- Cardiorespiratory failure
- Pregnancy and patients not giving informed consent for endoscopic procedures
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00905996
Start Date
August 1 2006
End Date
January 1 2009
Last Update
May 21 2009
Active Locations (1)
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1
Shiv K Sarin
New Delhi, National Capital Territory of Delhi, India, 110002