Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding

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

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2030-12-10

Brief Summary

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Carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension

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Detailed Description

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A Randomized controlled trial of carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension

Conditions

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Esophageal Varices

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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carvedilol

Carvedilol

Group Type EXPERIMENTAL

Carvedilol

Intervention Type DRUG

Carvedilol

Band Ligation

Group Type ACTIVE_COMPARATOR

Endoscopic band ligation

Intervention Type PROCEDURE

Endoscopic band ligation

Interventions

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Carvedilol

Intervention Type DRUG

Endoscopic band ligation

Intervention Type PROCEDURE

Other Intervention Names

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carvid band ligation

Eligibility Criteria

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Inclusion Criteria

* • Aged \>18 years

* Cirrhotic patients with arterial hypertension
* Endoscopic evidence of medium/large-sized esophageal varices

Exclusion Criteria

* • History of variceal bleeding or previous primary prevention of varices.

* Portal vein thrombosis or previous porto-systemic shunts as TIPS.
* Patients on drugs affecting portal pressure (beta blockers, nitrates).
* Advanced cardiovascular disease including acute myocardial infarction, atrio-ventricular block, congestive heart failure, chronic peripheral ischemia, severe bradycardia.
* Patients with severe respiratory diseases (COPD, bronchial asthma).
* Uncontrolled diabetes mellitus
* Renal impairment
* Hepatocellular carcinoma
* Allergy to carvedilol
* Pregnancy or lactation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No