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

ConditionEsophageal Varices

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorSherief Abd-Elsalam

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Aged >18 years

Cirrhotic patients with arterial hypertension

Endoscopic evidence of medium/large-sized esophageal varices

Disqualifiers

• 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.

Trial design

Design model

Parallel

Treatments tested in this trial

Carvedilol
Drug
Carvedilol
Endoscopic band ligation
Procedure/Surgery
Endoscopic band ligation

Treatment groups

306 Participants

are divided into 2 treatment groups

Group A: carvedilolExperimental treatment 1 intervention

Group B: Band LigationActive comparator 1 intervention

Trial outcomes

Primary outcomes

Number of patients with the first variceal bleeding within 1 year

The number of patients with the first variceal bleeding within 1 year

Time frame

1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sherief Abd-Elsalam

Lead sponsor

Tanta University

Sponsor institution

Source ClinicalTrials.gov

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