Banding Versus Propranolol for Primary Prophylaxis of Variceal Bleeding

University of Padova

Status and phase: Terminated; Phase 3

Conditions: Esophageal Varices; Liver Cirrhosis

Treatments: Drug: propranolol; Procedure: endoscopic variceal banding

Study type: Interventional

Funder types: Other

Identifiers

NCT00337740

TCPSVECE/9/01PD

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)