Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
ID04499898

Randomized Controlled Trial of Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding in Cirrhotic Patients With Arterial Hypertension

Led by Sherief Abd-Elsalam · Updated on 2020-08-05

306

Participants Needed

1

Research Sites

1 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial compares carvedilol, a medication, with endoscopic band ligation, a procedure, to prevent the first episode of bleeding from esophageal varices in patients who have liver cirrhosis and arterial hypertension. The study evaluates which method might better reduce the risk of variceal bleeding, a serious complication in these patients. It is a randomized controlled trial sponsored by Sherief Abd-Elsalam and includes adult participants aged 18 and older. Participants are randomly assigned to receive either carvedilol or undergo endoscopic band ligation. Carvedilol is given as a drug treatment, while endoscopic band ligation involves a procedure to tie off enlarged veins in the esophagus to prevent bleeding. The study monitors patients over a one-year period to compare the effects of these two approaches as primary prevention for variceal bleeding. During the study, participants will be assessed to see if they experience their first variceal bleeding within one year. Researchers will perform regular evaluations to monitor the patients' health and the condition of their esophageal varices. Safety and tolerability are also observed, with follow-up visits to track outcomes and any complications related to the treatments. The total participation time is at least one year based on the primary outcome measure.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged >18 years
  • Cirrhotic patients with arterial hypertension
  • Endoscopic evidence of medium or large-sized esophageal varices
Not Eligible

You will not qualify if you...

  • History of variceal bleeding or previous primary prevention of varices
  • Portal vein thrombosis or previous porto-systemic shunts such 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 such as COPD or bronchial asthma
  • Uncontrolled diabetes mellitus
  • Renal impairment
  • Hepatocellular carcinoma
  • Allergy to carvedilol
  • Pregnancy or lactation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 1 year

Participants receive either carvedilol medication or undergo endoscopic band ligation as primary prevention for esophageal variceal bleeding.

Trial Site Locations

Total: 1 location

1

Sherief Abd-Elsalam

Tanta, Egypt

Actively Recruiting

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Research Team

S

Sherief Abd-Elsalam, ass. prof.

N

Nabila el-gazzar, ass. lect.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Frequently Asked Questions

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