Primary Prophylaxis of Gastric Varix Bleed

NCT00905996 | Completed

• 1 other identifier: SRM04
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Bleeding from gastric varix or death

  Within 2 years

Secondary Outcomes (1)

• 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

Study Arms (3)

Endoscopic Cyanoacrylate injection

ACTIVE COMPARATOR

Endoscopic injection of cyanoacrylate in the gastric varix until obturation

Procedure: Endoscopic cyanoacrylate injection

No Intervention

NO INTERVENTION

No treatment offered for gastric varix

Beta-blocker (propranolol)

OTHER

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)

Interventions

Endoscopic cyanoacrylate injection PROCEDURE

Endoscopic cyanoacrylate injection in gastric varix

Also known as: Glue injection in gastric varix

Endoscopic Cyanoacrylate injection

Beta-blocker (propranolol) DRUG

Beta-blocker (propranolol)

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Govind Ballabh Pant Hospital: lead

Study Sites (1)

Shiv K Sarin

New Delhi, National Capital Territory of Delhi, 110002, India

Location

Related Publications (1)

• Mishra SR, Sharma BC, Kumar A, Sarin SK. Primary prophylaxis of gastric variceal bleeding comparing cyanoacrylate injection and beta-blockers: a randomized controlled trial. J Hepatol. 2011 Jun;54(6):1161-7. doi: 10.1016/j.jhep.2010.09.031. Epub 2010 Nov 5.

  PMID: 21145834 DERIVED

MeSH Terms

Conditions

Fibrosis

Interventions

Adhesives; Adrenergic beta-Antagonists; Propranolol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Physiological Effects of Drugs; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Shiv K Sarin, MD, DM

  G B Pant Hospital, New Delhi, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 21, 2009
• Study Start: August 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: May 21, 2009

Record last verified: 2009-05

Locations

IN (1)