Primary Prophylaxis of Gastric Varix Bleed

This study has been completed.
Sponsor:
Information provided by:
Govind Ballabh Pant Hospital
ClinicalTrials.gov Identifier:
NCT00905996
First received: May 19, 2009
Last updated: May 20, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention
Cirrhosis
Procedure: Endoscopic cyanoacrylate injection
Drug: Beta-blocker (propranolol)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial Comparing Cyanoacrylate Injection Versus Beta-Blockers Versus No Treatment for Primary Prophylaxis of Gastric Variceal Bleed

Resource links provided by NLM:


Further study details as provided by Govind Ballabh Pant Hospital:

Primary Outcome Measures:
  • Bleeding from gastric varix or death [ Time Frame: Within 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increase or decrease in the size of gastric varices, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy (PGP), complications [ Time Frame: Within 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 74
Study Start Date: August 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Endoscopic Cyanoacrylate injection
Endoscopic injection of cyanoacrylate in the gastric varix until obturation
Procedure: Endoscopic cyanoacrylate injection
Endoscopic cyanoacrylate injection in gastric varix
Other Name: Glue injection in gastric varix
No Intervention: No Intervention
No treatment offered for gastric varix
Beta-blocker (propranolol)
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)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905996

Locations
India
Shiv K Sarin
New Delhi, Delhi, India, 110002
Sponsors and Collaborators
Govind Ballabh Pant Hospital
Investigators
Principal Investigator: Shiv K Sarin, MD, DM G B Pant Hospital, New Delhi, India
  More Information

No publications provided by Govind Ballabh Pant Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr S K Sarin, Department of Gastroenterology, G B Pant Hospital, New Delhi, India
ClinicalTrials.gov Identifier: NCT00905996     History of Changes
Other Study ID Numbers: SRM04
Study First Received: May 19, 2009
Last Updated: May 20, 2009
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on September 16, 2014