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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

Page last updated: October 19, 2009

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