Primary Prophylaxis of Gastric Varix Bleed

Cirrhosis Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Cyanoacrylate Injection Versus Beta-Blockers Versus No Treatment for Primary Prophylaxis of Gastric Variceal Bleed

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00905996
• Other study ID #: SRM04
• Status: Completed
• Phase: N/A
• First received: May 19, 2009
• Last updated: May 20, 2009
• Start date: August 2006
• Est. completion date: January 2009

Study information

• Verified date: May 2009
• Source: Govind Ballabh Pant Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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 investigators conducted a randomized controlled trial in patients with gastric varix (GOV2 and IGV1) who never bled before, to study the efficacy of treatment with cyanoacrylate injection versus beta-blocker versus no treatment in prevention of first bleed from gastric varices.

Description:

Patients are followed up every 3 months or at the time of end point or complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with GOV2 with eradicated esophageal varix or IGV1, who had never bled from gastric varix were included.

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cirrhosis

Intervention

Procedure:
• Endoscopic cyanoacrylate injection
Endoscopic cyanoacrylate injection in gastric varix

Drug:
• Beta-blocker (propranolol)

Locations

Country	Name	City	State
India	Shiv K Sarin	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Govind Ballabh Pant Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding from gastric varix or death		Within 2 years	No
Secondary	Increase or decrease in the size of gastric varices, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy (PGP), complications		Within 2 years	Yes