Status:
COMPLETED
Secondary Prophylaxis Gastric Variceal Bleed
Lead Sponsor:
Govind Ballabh Pant Hospital
Conditions:
Cirrhosis
Eligibility:
All Genders
10-70 years
Phase:
NA
Brief Summary
The investigators conducted a randomized, controlled trial (RCT) to study the efficacy of beta blockers versus endoscopic cyanoacrylate injection in the prevention of gastric variceal (GOV2 or IGV1) r...
Eligibility Criteria
Inclusion
- Patients with GOV2 without esophageal varix or IGV1, who had bled from GV were included
Exclusion
- Presence of esophageal varix
- GOV2 with GOV1; contraindications to beta-blocker therapy and cyanoacrylate injection
- Prior injection of cyanoacrylate or sclerotherapy for GV or GV ligation, transjugular intrahepatic portosystemic shunt, balloon-occluded retrograde transvenous obliteration, balloon-occluded endoscopic injection sclerotherapy of GV, shunt operation for prevention of rebleeding 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 or 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 :
64 Patients enrolled
Trial Details
Trial ID
NCT00888784
Start Date
August 1 2006
End Date
January 1 2009
Last Update
April 28 2009
Active Locations (1)
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1
G B Pant Hospital
New Delhi, National Capital Territory of Delhi, India, 110002