Banding Versus Propranolol for Primary Prophylaxis of Variceal Bleeding

Liver Cirrhosis Clinical Trial

Official title:

Randomized Study Comparing Ligation With Propranolol for Primary Prophylaxis of Variceal Bleeding in Candidates for Liver Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00337740
• Other study ID #: TCPSVECE/9/01PD
• Status: Terminated
• Phase: Phase 3
• First received: June 14, 2006
• Last updated: April 20, 2012

Study information

• Verified date: September 2006
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Esophageal Varices
• Liver Cirrhosis

Intervention

Procedure:
• endoscopic variceal banding

Drug:
• propranolol

Locations

Country	Name	City	State
Italy	Clinica Chirurgica 1^, Policlinico Universitario, Via Giustiniani 2	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	variceal bleeding