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TerminatedNCT00337740Updated Apr 23, 2012

Banding Versus Propranolol for Primary Prophylaxis of Variceal Bleeding

A Phase 3 interventional study of endoscopic variceal banding and propranolol in Liver Cirrhosis and Esophageal Varices, sponsored by University of Padova. Terminated at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-04-23.

Sponsored by University of Padova · Phase 3, Interventional, and Prevention

Why this study was terminated
From the interim analysis resulted that more than 1000 patients were required to demonstrate a significant difference between the 2 treatments.
Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Liver Cirrhosis
  • Esophageal Varices
03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's planned enrollment of 120 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

University of Padova is the lead sponsor of 210 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Interventions

  • Procedureendoscopic variceal banding
  • Drugpropranolol
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What researchers measure

Primary outcomes

  1. variceal bleeding

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Study locations

1 site
  • Clinica Chirurgica 1^, Policlinico Universitario, Via Giustiniani 2
    Padova, 35128, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00337740
Lead sponsor
University of Padova
First posted
Jun 16, 2006
Last update
Apr 23, 2012

Study contacts

Lorenzo Norberto, prof, M.D.
principal investigator · University of Padova, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic
Umberto Cillo, prof. M.D.
principal investigator · University of Padova, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic
Francesco Grigoletto, prof, M.D.
study director · Biostatistic and Epidemiology Unit, Department of Enviromental Medicine and Public Health, University of Padova, Italy
Davide D'Amico, prof, MD
study chair · Padova University, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Sep 2006. You cannot join it, but the record below documents what was studied.

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