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Study protocol for a randomised controlled trial of carvedilol versus variceal band ligation in primary prevention of variceal bleeding in liver cirrhosis (CALIBRE trial)

INTRODUCTION: Liver cirrhosis is the fifth largest cause of adult deaths, and a major complication, variceal bleeding is associated with a 1-year mortality of 40%. There is uncertainty on the first-line therapy for prevention of variceal bleeding owing to a lack of adequately powered trials comparin...

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Autores principales: Tripathi, Dhiraj, Hayes, Peter Clive, Richardson, Paul, Rowe, Ian, Ferguson, James, Devine, Peter, Mathers, Jonathan, Poyner, Christopher, Jowett, Sue, Handley, Kelly, Grant, Margaret, Slinn, Gemma, Ahmed, Khaled, Brocklehurst, Peter
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6506059/
https://www.ncbi.nlm.nih.gov/pubmed/31139428
http://dx.doi.org/10.1136/bmjgast-2019-000290
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author Tripathi, Dhiraj
Hayes, Peter Clive
Richardson, Paul
Rowe, Ian
Ferguson, James
Devine, Peter
Mathers, Jonathan
Poyner, Christopher
Jowett, Sue
Handley, Kelly
Grant, Margaret
Slinn, Gemma
Ahmed, Khaled
Brocklehurst, Peter
author_facet Tripathi, Dhiraj
Hayes, Peter Clive
Richardson, Paul
Rowe, Ian
Ferguson, James
Devine, Peter
Mathers, Jonathan
Poyner, Christopher
Jowett, Sue
Handley, Kelly
Grant, Margaret
Slinn, Gemma
Ahmed, Khaled
Brocklehurst, Peter
author_sort Tripathi, Dhiraj
collection PubMed
description INTRODUCTION: Liver cirrhosis is the fifth largest cause of adult deaths, and a major complication, variceal bleeding is associated with a 1-year mortality of 40%. There is uncertainty on the first-line therapy for prevention of variceal bleeding owing to a lack of adequately powered trials comparing non-selective beta blockers, in particular carvedilol, with variceal band ligation. METHODS AND ANALYSIS: CALIBRE is a multicentre, pragmatic, randomised controlled, open-label trial with an internal pilot. The two interventions are carvedilol 12.5 mg od or variceal band ligation (VBL). Patients with liver cirrhosis and medium to large oesophageal varices that have never bled are eligible for inclusion. The primary outcome is any variceal bleeding within 1 year of randomisation. Secondary endpoints include time to variceal bleed, mortality, transplant-free survival, adverse events, complications of cirrhosis, health-related quality of life, use of healthcare resources, patient preference and use of alternative or crossover therapies. The sample size is 2630 patients over a 4-year recruitment period, across 66 hospitals in the UK. ETHICS AND DISSEMINATION: The study has been approved by a National Health Service (NHS) Research Ethics Committee (REC) (reference number 18/NE/0296). The results of this trial will be submitted for publication in a peer reviewed journal. Participants will be informed via a link to a preview of the publication. A lay summary will also be provided via email or posted to participants prior to publication (ISRCTN reference number: 73887615).
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spelling pubmed-65060592019-05-28 Study protocol for a randomised controlled trial of carvedilol versus variceal band ligation in primary prevention of variceal bleeding in liver cirrhosis (CALIBRE trial) Tripathi, Dhiraj Hayes, Peter Clive Richardson, Paul Rowe, Ian Ferguson, James Devine, Peter Mathers, Jonathan Poyner, Christopher Jowett, Sue Handley, Kelly Grant, Margaret Slinn, Gemma Ahmed, Khaled Brocklehurst, Peter BMJ Open Gastroenterol Hepatology INTRODUCTION: Liver cirrhosis is the fifth largest cause of adult deaths, and a major complication, variceal bleeding is associated with a 1-year mortality of 40%. There is uncertainty on the first-line therapy for prevention of variceal bleeding owing to a lack of adequately powered trials comparing non-selective beta blockers, in particular carvedilol, with variceal band ligation. METHODS AND ANALYSIS: CALIBRE is a multicentre, pragmatic, randomised controlled, open-label trial with an internal pilot. The two interventions are carvedilol 12.5 mg od or variceal band ligation (VBL). Patients with liver cirrhosis and medium to large oesophageal varices that have never bled are eligible for inclusion. The primary outcome is any variceal bleeding within 1 year of randomisation. Secondary endpoints include time to variceal bleed, mortality, transplant-free survival, adverse events, complications of cirrhosis, health-related quality of life, use of healthcare resources, patient preference and use of alternative or crossover therapies. The sample size is 2630 patients over a 4-year recruitment period, across 66 hospitals in the UK. ETHICS AND DISSEMINATION: The study has been approved by a National Health Service (NHS) Research Ethics Committee (REC) (reference number 18/NE/0296). The results of this trial will be submitted for publication in a peer reviewed journal. Participants will be informed via a link to a preview of the publication. A lay summary will also be provided via email or posted to participants prior to publication (ISRCTN reference number: 73887615). BMJ Publishing Group 2019-04-25 /pmc/articles/PMC6506059/ /pubmed/31139428 http://dx.doi.org/10.1136/bmjgast-2019-000290 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Hepatology
Tripathi, Dhiraj
Hayes, Peter Clive
Richardson, Paul
Rowe, Ian
Ferguson, James
Devine, Peter
Mathers, Jonathan
Poyner, Christopher
Jowett, Sue
Handley, Kelly
Grant, Margaret
Slinn, Gemma
Ahmed, Khaled
Brocklehurst, Peter
Study protocol for a randomised controlled trial of carvedilol versus variceal band ligation in primary prevention of variceal bleeding in liver cirrhosis (CALIBRE trial)
title Study protocol for a randomised controlled trial of carvedilol versus variceal band ligation in primary prevention of variceal bleeding in liver cirrhosis (CALIBRE trial)
title_full Study protocol for a randomised controlled trial of carvedilol versus variceal band ligation in primary prevention of variceal bleeding in liver cirrhosis (CALIBRE trial)
title_fullStr Study protocol for a randomised controlled trial of carvedilol versus variceal band ligation in primary prevention of variceal bleeding in liver cirrhosis (CALIBRE trial)
title_full_unstemmed Study protocol for a randomised controlled trial of carvedilol versus variceal band ligation in primary prevention of variceal bleeding in liver cirrhosis (CALIBRE trial)
title_short Study protocol for a randomised controlled trial of carvedilol versus variceal band ligation in primary prevention of variceal bleeding in liver cirrhosis (CALIBRE trial)
title_sort study protocol for a randomised controlled trial of carvedilol versus variceal band ligation in primary prevention of variceal bleeding in liver cirrhosis (calibre trial)
topic Hepatology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6506059/
https://www.ncbi.nlm.nih.gov/pubmed/31139428
http://dx.doi.org/10.1136/bmjgast-2019-000290
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