Banding Versus Propranolol for Primary Prophylaxis of Variceal Bleeding

Phase 3

Terminated

• Conditions: Liver Cirrhosis; Esophageal Varices

• Registration Number: NCT00337740
• Lead Sponsor: University of Padova

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-14
• Study First Submitted QC: 2006-06-15
• Study First Posted: 2006-06-16
• Status Verified: 2006-09
• Last Update Submitted: 2012-04-20
• Last Update Posted: 2012-04-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
variceal bleeding

Trial Locations

Locations (1)

Clinica Chirurgica 1^, Policlinico Universitario, Via Giustiniani 2; 🇮🇹 Padova, Italy