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Secondary Prophylaxis Gastric Variceal Bleed

This study has been completed.
Sponsor:
Information provided by:
Govind Ballabh Pant Hospital
ClinicalTrials.gov Identifier:
NCT00888784
First received: April 27, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted

April 27, 2009
April 27, 2009
August 2006
January 2009   (final data collection date for primary outcome measure)
Rebleeding from GV or death [ Time Frame: Overall Study ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Secondary Prophylaxis Gastric Variceal Bleed
Endoscopic Cyanoacrylate Injection Versus Beta-Blockers for Secondary Prophylaxis of Gastric Variceal Bleed

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Cirrhosis
  • 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.
  • 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)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
10 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00888784
SRM03
No
Shiv K Sarin, G B Pant Hospital
Govind Ballabh Pant Hospital
Not Provided
Principal Investigator: Shiv K Sarin, MD, DM Director, G B Pant Hospital
Govind Ballabh Pant Hospital
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP