Secondary Prophylaxis Gastric Variceal Bleed

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1. Endoscopic Cyanoacrylate injection

Endoscopic Cyanoacrylate injection in the gastric varix

Group Type ACTIVE_COMPARATOR

Endoscopic Cyanoacrylate injection

Intervention Type PROCEDURE

Endoscopic Cyanoacrylate injection in gastric varix

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.

Group Type PLACEBO_COMPARATOR

beta-blocker (propranolol)

Intervention Type 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.

Interventions

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Endoscopic Cyanoacrylate injection

Endoscopic Cyanoacrylate injection in gastric varix

Intervention Type PROCEDURE

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.

Intervention Type DRUG

Other Intervention Names

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Glue injection

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No