Secondary Prophylaxis Gastric Variceal Bleed

NCT00888784 | Completed

• 1 other identifier: SRM03
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Rebleeding from GV or death

  Overall Study

Secondary Outcomes (1)

• Increase or decrease in the size of GV, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy and complications.

  Overall Study

Study Arms (2)

1. Endoscopic Cyanoacrylate injection

ACTIVE COMPARATOR

Endoscopic Cyanoacrylate injection in the gastric varix

Procedure: Endoscopic Cyanoacrylate injection

2. Beta-blocker

PLACEBO COMPARATOR

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

1. Endoscopic Cyanoacrylate injection

beta-blocker (propranolol) DRUG

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.

2. Beta-blocker

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Govind Ballabh Pant Hospital: lead

Study Sites (1)

G B Pant Hospital

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

Location

Related Publications (1)

• 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.

  PMID: 20551457 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

  Director, G B Pant Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 27, 2009
• First Posted: April 28, 2009
• Study Start: August 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: April 28, 2009

Record last verified: 2009-04

Locations

IN (1)