Secondary Prophylaxis Gastric Variceal Bleed

• ClinicalTrials.gov Identifier: NCT00888784
• Recruitment Status: Completed
• First Posted: April 28, 2009
• Last Update Posted: April 28, 2009
• Sponsor: Govind Ballabh Pant Hospital
• Information provided by: Govind Ballabh Pant Hospital

Tracking Information

• First Submitted Date: April 27, 2009
• First Posted Date: April 28, 2009
• Last Update Posted Date: April 28, 2009
• Study Start Date: August 2006
• Actual Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 27, 2009): Rebleeding from GV or death [ Time Frame: Overall Study ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: April 27, 2009): Increase or decrease in the size of GV, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy and complications. [ Time Frame: Overall Study ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Secondary Prophylaxis Gastric Variceal Bleed
• Official Title: Endoscopic Cyanoacrylate Injection Versus Beta-Blockers for Secondary Prophylaxis of Gastric Variceal Bleed
• 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) rebleeding and improvement in survival.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Cirrhosis

Intervention

• Procedure: Endoscopic Cyanoacrylate injection
  Endoscopic Cyanoacrylate injection in gastric varix
  Other Name: Glue injection
• Drug: beta-blocker (propranolol)
  Propranolol was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was >90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure <90 mm Hg or pulse rate <55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect.

Study Arms

• Active Comparator: 1. Endoscopic Cyanoacrylate injection
  Endoscopic Cyanoacrylate injection in the gastric varix
  Intervention: Procedure: Endoscopic Cyanoacrylate injection
• Placebo Comparator: 2. Beta-blocker
  Propranolol was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was >90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure <90 mm Hg or pulse rate <55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect.
  Intervention: Drug: beta-blocker (propranolol)

• Publications *: Mishra SR, Chander Sharma B, Kumar A, Sarin SK. Endoscopic cyanoacrylate injection versus beta-blocker for secondary prophylaxis of gastric variceal bleed: a randomised controlled trial. Gut. 2010 Jun;59(6):729-35. doi: 10.1136/gut.2009.192039.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 27, 2009): 64
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 2009
• Actual Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients with GOV2 without esophageal varix or IGV1, who had bled from GV were included

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 10 Years to 70 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT00888784
• Other Study ID Numbers: SRM03
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Shiv K Sarin, G B Pant Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Govind Ballabh Pant Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Shiv K Sarin, MD, DM; Director, G B Pant Hospital

• PRS Account: Govind Ballabh Pant Hospital
• Verification Date: April 2009