Banding Versus Propranolol for Primary Prophylaxis of Variceal Bleeding
Information source: University of Padova
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Cirrhosis; Esophageal Varices
Intervention: endoscopic variceal banding (Procedure); propranolol (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of Padova Official(s) and/or principal investigator(s):
Lorenzo Norberto, prof, M.D., Principal Investigator, Affiliation: University of Padova, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic
Umberto Cillo, prof. M.D., Principal Investigator, Affiliation: University of Padova, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic
Francesco Grigoletto, prof, M.D., Study Director, Affiliation: Biostatistic and Epidemiology Unit, Department of Enviromental Medicine and Public Health, University of Padova, Italy
Davide D'Amico, prof, MD, Study Chair, Affiliation: Padova University, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic
Overall contact:
Lorenzo Norberto, prof, Phone: 0039-0498212211, Email: lorenzo.norberto@unipd.it
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
Clinical Details
Official title: Randomized Study Comparing Ligation With Propranolol for Primary Prophylaxis of Variceal Bleeding in Candidates for Liver Transplantation
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: variceal bleeding
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Lorenzo Norberto, prof, Phone: 0039-0498212211, Email: lorenzo.norberto@unipd.it
Clinica Chirurgica 1^, Policlinico Universitario, Via Giustiniani 2, Padova 35128, Italy; Recruiting
Lorenzo Norberto, prof, Phone: 0039-0498212211, Email: lorenzo.norberto@unipd.it
Lorenzo Norberto, prof., M.D., Principal Investigator
Umberto Cillo, prof. M.D., Principal Investigator
Giacomo Zanus, M.D., Sub-Investigator
Lino Polese, M.D., Sub-Investigator
Patrizia Burra, MD, Sub-Investigator
Additional Information
Starting date: September 2001
Last updated: June 15, 2006
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