Liver CirrhosisPhase 3NCT00337740
Banding Versus Propranolol for Primary Prophylaxis of Variceal Bleeding
A Phase 3 study testing endoscopic variceal banding and propranolol in people with Liver Cirrhosis and Esophageal Varices, run by University of Padova at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Cirrhosis, Esophageal Varices
- What is being tested?
- endoscopic variceal banding and propranolol
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- liver cirrhosis
- child pugh>=B7
- studied for transplantation
- age between 18 an 65 ys
- no previous bleeding from varices
- signed informed consent
Who cannot join
- 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
Show all 11Show fewer
- contraindications to betablockers
- treatment with nitrates, calcium antagonist or anti-arhythmic drugs that can not be suspended
- Pregnancy
- neoplasias
- non cooperation
Trial locations and contacts
1 site in 1 country.
Italy1 site
Clinica Chirurgica 1^, Policlinico Universitario, Via Giustiniani 2
Padova, 35128
About this study
Official title: Randomized Study Comparing Ligation With Propranolol for Primary Prophylaxis of Variceal Bleeding in Candidates for Liver Transplantation
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
- Conditions
- Liver Cirrhosis, Esophageal Varices
- Being tested
- endoscopic variceal banding, propranolol
- Medical subject headings
- Liver Cirrhosis, Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic variceal bandingProcedure or surgery
propranololDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
variceal bleeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2006 (estimated)
Why it stopped: From the interim analysis resulted that more than 1000 patients were required to demonstrate a significant difference between the 2 treatments.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Investigators
- Lorenzo Norberto, prof, M.D., Principal investigator, University of Padova, Department of Surgical and Gastroenterological Sciences, 1st Surgical ClinicUmberto Cillo, prof. M.D., Principal investigator, University of Padova, Department of Surgical and Gastroenterological Sciences, 1st Surgical ClinicFrancesco Grigoletto, prof, M.D., Study director, Biostatistic and Epidemiology Unit, Department of Enviromental Medicine and Public Health, University of Padova, ItalyDavide D'Amico, prof, MD, Study chair, Padova University, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337740
- Sponsor's protocol ID
- TCPSVECE/9/01PD
- Status last verified
- Sep 2006
- First submitted
- 14 Jun 2006
- Last updated
- 23 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Comparing Ligation With Propranolol for Primary Prophylaxis of Variceal Bleeding in Candidates for Liver Transplantation
- ClinicalTrials.gov ID
- NCT00337740
- Acronym / sponsor ID
- TCPSVECE/9/01PD
- Conditions
- Liver Cirrhosis, Esophageal Varices
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: From the interim analysis resulted that more than 1000 patients were required to demonstrate a significant difference between the 2 treatments.
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- First posted
- 16 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- liver cirrhosis
- child pugh>=B7
- studied for transplantation
- age between 18 an 65 ys
- no previous bleeding from varices
Key exclusion criteria (11 listed)
- esophageal varices less than F2 blue
- gastric varices
- previous variceal surgical or radiological or endoscopical treatment
- hepatocarcinoma
- portal vein thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic variceal banding | Procedure or surgery | – |
| propranolol | Drug | – |
Primary outcome
variceal bleeding
Results and safety
The study was stopped early (reason given: From the interim analysis resulted that more than 1000 patients were required to demonstrate a significant difference between the 2 treatments.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing endoscopic variceal banding and propranolol in people with Liver Cirrhosis and Esophageal Varices, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: From the interim analysis resulted that more than 1000 patients were required to demonstrate a significant difference between the 2 treatments.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variceal bleeding. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2012.