NCT00337740

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2006

Completed
Last Updated

April 23, 2012

Status Verified

September 1, 2006

First QC Date

June 14, 2006

Last Update Submit

April 20, 2012

Conditions

Liver CirrhosisEsophageal Varices

Outcome Measures

Primary Outcomes (1)

  • variceal bleeding

Interventions

endoscopic variceal bandingPROCEDURE
propranololDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • liver cirrhosis
  • child pugh\>=B7
  • studied for transplantation
  • age between 18 an 65 ys
  • no previous bleeding from varices
  • signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Chirurgica 1^, Policlinico Universitario, Via Giustiniani 2

Padua, 35128, Italy

Location

MeSH Terms

Conditions

Liver CirrhosisEsophageal and Gastric Varices

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsEsophageal DiseasesGastrointestinal DiseasesHypertension, Portal

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Lorenzo Norberto, prof, M.D.

    University of Padova, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic

    PRINCIPAL INVESTIGATOR

  • Umberto Cillo, prof. M.D.

    University of Padova, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic

    PRINCIPAL INVESTIGATOR

  • Francesco Grigoletto, prof, M.D.

    Biostatistic and Epidemiology Unit, Department of Enviromental Medicine and Public Health, University of Padova, Italy

    STUDY DIRECTOR

  • Davide D'Amico, prof, MD

    Padova University, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 14, 2006

First Posted

June 16, 2006

Last Updated

April 23, 2012

Record last verified: 2006-09

Locations

IT(1)