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

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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). / Tripathi, Dhiraj; Hayes, Peter; Richardson, Paul ; Rowe, Ian A; Fersuon, James Walter ; Devine, Peter ; Mathers, Jonathan; Poyner, Christopher; Jowett, Sue; Handley, Kelly; Grant, Margaret; Slinn, Gemma; Brocklehurst, Peter; Ahmed, Khaled.

In: BMJ Open Gastroenterology, Vol. 6, No. 1, e000290, 25.04.2019.

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@article{b09ba09260af46f58c0bb8eca2bd89d1,
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)",
abstract = "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.",
keywords = "cirrhosis, gastrointestinal bleeding, oesophageal varices, portal hypertension",
author = "Dhiraj Tripathi and Peter Hayes and Paul Richardson and Rowe, {Ian A} and Fersuon, {James Walter} and Peter Devine and Jonathan Mathers and Christopher Poyner and Sue Jowett and Kelly Handley and Margaret Grant and Gemma Slinn and Peter Brocklehurst and Khaled Ahmed",
year = "2019",
month = apr,
day = "25",
doi = "10.1136/ bmjgast-2019-000290",
language = "English",
volume = "6",
journal = "BMJ Open Gastroenterology",
issn = "2054-4774",
publisher = "BMJ Publishing Group",
number = "1",

}

RIS

TY - JOUR

T1 - Study protocol for a randomised controlled trial of carvedilol versus variceal band ligation in primary prevention of variceal bleeding in liver cirrhosis (CALIBRE trial)

AU - Tripathi, Dhiraj

AU - Hayes, Peter

AU - Richardson, Paul

AU - Rowe, Ian A

AU - Fersuon, James Walter

AU - Devine, Peter

AU - Mathers, Jonathan

AU - Poyner, Christopher

AU - Jowett, Sue

AU - Handley, Kelly

AU - Grant, Margaret

AU - Slinn, Gemma

AU - Brocklehurst, Peter

AU - Ahmed, Khaled

PY - 2019/4/25

Y1 - 2019/4/25

N2 - 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.

AB - 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.

KW - cirrhosis

KW - gastrointestinal bleeding

KW - oesophageal varices

KW - portal hypertension

UR - http://www.scopus.com/inward/record.url?scp=85065163800&partnerID=8YFLogxK

U2 - 10.1136/ bmjgast-2019-000290

DO - 10.1136/ bmjgast-2019-000290

M3 - Article

VL - 6

JO - BMJ Open Gastroenterology

JF - BMJ Open Gastroenterology

SN - 2054-4774

IS - 1

M1 - e000290

ER -