Primary Prophylaxis of Gastric Varix 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

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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

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

SINGLE

Participants

Study Groups

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Endoscopic Cyanoacrylate injection

Endoscopic injection of cyanoacrylate in the gastric varix until obturation

Group Type ACTIVE_COMPARATOR

Endoscopic cyanoacrylate injection

Intervention Type PROCEDURE

Endoscopic cyanoacrylate injection in gastric varix

No Intervention

No treatment offered for gastric varix

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type OTHER

Beta-blocker (propranolol)

Intervention Type DRUG

Interventions

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Endoscopic cyanoacrylate injection

Endoscopic cyanoacrylate injection in gastric varix

Intervention Type PROCEDURE

Beta-blocker (propranolol)

Intervention Type DRUG

Other Intervention Names

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Glue injection in gastric varix

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No