Banding Versus Propranolol for Primary Prophylaxis of 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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Brief Summary

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Whether beta-blockers or banding is the best therapy for primary prophylaxis of variceal bleeding is subject to debate. A randomized comparison between the two treatments was performed in candidates for liver transplantation. Patients with Child B and C cirrhosis with high risk varices and no previous variceal bleeding are randomized to propranolol or variceal bleeding. Primary end point is variceal bleeding

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Detailed Description

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Conditions

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Liver Cirrhosis Esophageal Varices

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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endoscopic variceal banding

Intervention Type PROCEDURE

propranolol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* liver cirrhosis
* child pugh\>=B7
* studied for transplantation
* age between 18 an 65 ys
* no previous bleeding from varices
* signed informed consent

Exclusion Criteria

* esophageal varices less than F2 blue
* gastric varices
* previous variceal surgical or radiological or endoscopical treatment
* hepatocarcinoma
* portal vein thrombosis
* severe heart, respiratory or renal failure
* contraindications to betablockers
* treatment with nitrates, calcium antagonist or anti-arhythmic drugs that can not be suspended
* Pregnancy
* neoplasias
* non cooperation

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No