Secondary Prophylaxis Gastric Variceal Bleed - Full Text View

Purpose

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	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: Open Label Primary Purpose: Prevention
Official Title:	Endoscopic Cyanoacrylate Injection Versus Beta-Blockers for Secondary Prophylaxis of Gastric Variceal Bleed

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis Endoscopy Varicose Veins

Drug Information available for: Propranolol hydrochloride Propranolol

U.S. FDA Resources

Further study details as provided by Govind Ballabh Pant Hospital:

Primary Outcome Measures:

Rebleeding from GV or death [ Time Frame: Overall Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	64
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: 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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	10 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888784

Locations

India
G B Pant Hospital
New Delhi, Delhi, India, 110002

Sponsors and Collaborators

Govind Ballabh Pant Hospital

Investigators

Principal Investigator:

Shiv K Sarin, MD, DM

Director, G B Pant Hospital

More Information

No publications provided by Govind Ballabh Pant Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Shiv K Sarin, G B Pant Hospital
ClinicalTrials.gov Identifier:	NCT00888784 History of Changes
Other Study ID Numbers:	SRM03
Study First Received:	April 27, 2009
Last Updated:	April 27, 2009
Health Authority:	India: Ministry of Health

Additional relevant MeSH terms:

Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes
Adrenergic beta-Antagonists
Propranolol
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 May 23, 2013