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Secondary Prophylaxis Gastric Variceal Bleed

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cirrhosis Procedure: Endoscopic Cyanoacrylate injection Drug: beta-blocker (propranolol) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Endoscopic Cyanoacrylate Injection Versus Beta-Blockers for Secondary Prophylaxis of Gastric Variceal Bleed
Study Start Date : August 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1. Endoscopic Cyanoacrylate injection
Endoscopic Cyanoacrylate injection in the gastric varix
 Procedure: Endoscopic Cyanoacrylate injection
Endoscopic Cyanoacrylate injection in gastric varix
Other Name: Glue 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Rebleeding from GV or death [ Time Frame: Overall Study ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   10 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888784


Locations
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India
G B Pant Hospital
New Delhi, Delhi, India, 110002
Sponsors and Collaborators
Govind Ballabh Pant Hospital
Investigators
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Principal Investigator: Shiv K Sarin, MD, DM Director, G B Pant Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shiv K Sarin, G B Pant Hospital
ClinicalTrials.gov Identifier: NCT00888784    
Other Study ID Numbers: SRM03
First Posted: April 28, 2009    Key Record Dates
Last Update Posted: April 28, 2009
Last Verified: April 2009
Additional relevant MeSH terms:
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Fibrosis
Pathologic Processes
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents