Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of oesophageal varices: study protocol for a randomised controlled trial Article Swipe

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Vishal Patel , Mark McPhail , Ruhama Uddin , Hassan Jafari , Vanessa Lawrence , Clair Le Boutillier , James Shearer , Nahel Yaziji , Angela Cape , Haroon Ahmed , Christopher D. Ward , Peter Walsh , Kevin Besly , Ane Zamalloa , Joanna Kelly , Ashis Mukhopadhya , Alicija Vileito , Tracy Henderson , Gwilym J. Webb , Jerrian Joyce Andrada , Abigail Ford , Cyril Sieberhagen , Claire Burston , Carol Brooks , Gavin Wright , Bushena Miyesa , Aimee Williams , Jay Patel , Melchizedek Penacerrada , Gautham Appanna , Gifthy Perez , Joanne Elliott , Keval Naik , Susan Smolen , Anna Beckwith , Matthew Foxton , Carina Bautista , Matthew Cramp , Ada Laureen Nweze , Gayatri Chakrabarty , Indhuja Rajkumar , Merlin James , Steven Masson , Sheenu Thomas , Lucy Dixon , S. Hogg , Louise Finlay , Kuldeep Cheent , Jessica K. Camp , Adrian J. Stanley , Alexis Duncan , Lauren Walker , Duncan Napier , Paula Hilltout , Linda Hill , Hiromi Uzu , Moby Joseph , Suzannah Pegler , Camille Walling , Lynsey Corless , Anisoara Kingsbury , Tania Nurun , Debasish Das , Anna Williams , Stephen Foley , C W Goodwin , Markus Gess , Margaret Grout , Ka‐Kit Li , Olivia Watchorn , Laura S. Plummer , Laura Blackmore , Christos Tsintikidis , Alexia A. Perryman , G. W. G. Bird , Emily Phiri , Mohamed Saleh , A.O. Woghiren , Dilukshi Wickramasinghe , Jodie Wright , Michael H. Miller , Shona Murray , Leanne Cosgrove , John Hutchinson , Julie Burton , E Stoner , Stephanie Lupton , Mayur Kumar , Nicola Griffiths , Anna Posada , Andrew Fowell , Avisnata Das , Jincy Daniel , Anu Rose Andrews , Dhiraj Tripathi , Emma Burke , E. R. EAVES , H Emms , Dina Mansour , Ann Wilson ·

YOU? · · 2024 · Open Access · · DOI: https://doi.org/10.1186/s13063-024-08063-3

Background Liver disease is within the top five causes of premature death in adults. Deaths caused by complications of cirrhosis continue to rise, whilst deaths related to other non-liver disease areas are declining. Portal hypertension is the primary sequelae of cirrhosis and is associated with the development of variceal haemorrhage, ascites, hepatic encephalopathy and infection, collectively termed hepatic decompensation, which leads to hospitalisation and mortality. It remains uncertain whether administering a non-selective beta-blocker (NSBB), specifically carvedilol, at an earlier stage, i.e. when oesophageal varices are small, can prevent VH and reduce all-cause decompensation (ACD). Methods/design The BOPPP trial is a pragmatic, multicentre, placebo-controlled, triple-blinded, randomised controlled trial (RCT) in England, Scotland, Wales and Northern Ireland. Patients aged 18 years or older with cirrhosis and small oesophageal varices that have never bled will be recruited, subject to exclusion criteria. The trial aims to enrol 740 patients across 55 hospitals in the UK. Patients are allocated randomly on a 1:1 ratio to receive either carvedilol 6.25 mg (a NSBB) or a matched placebo, once or twice daily, for 36 months, to attain adequate power to determine the effectiveness of carvedilol in preventing or reducing ACD. The primary outcome is the time to first decompensating event. It is a composite primary outcome made up of variceal haemorrhage (VH, new or worsening ascites, new or worsening hepatic encephalopathy (HE), spontaneous bacterial peritonitis (SBP), hepatorenal syndrome, an increase in Child–Pugh grade by 1 grade or MELD score by 5 points, and liver-related mortality. Secondary outcomes include progression to medium or large oesophageal varices, development of gastric, duodenal, or ectopic varices, participant quality of life, healthcare costs and transplant-free survival. Discussion The BOPPP trial aims to investigate the clinical and cost-effectiveness of carvedilol in patients with cirrhosis and small oesophageal varices to determine whether this non-selective beta-blocker can prevent or reduce hepatic decompensation. There is clinical equipoise on whether intervening in cirrhosis, at an earlier stage of portal hypertension, with NSBB therapy is beneficial. Should the trial yield a positive result, we anticipate that the administration and use of carvedilol will become widespread with pathways developed to standardise the administration of the medication in primary care. Ethics and dissemination The trial has been approved by the National Health Service (NHS) Research Ethics Committee (REC) (reference number: 19/YH/0015). The results of the trial will be submitted for publication in a peer-reviewed scientific journal. Participants will be informed of the results via the BOPPP website ( www.boppp-trial.org ) and partners in the British Liver Trust (BLT) organisation. Trial registration EUDRACT reference number: 2018–002509-78. ISRCTN reference number: ISRCTN10324656. Registered on April 24 2019.

Related Topics

Hepatic Encephalopathy

Hepatorenal Syndrome

Randomized Controlled Trial

Concepts

Medicine Spontaneous bacterial peritonitis Carvedilol Varices Cirrhosis Hepatic encephalopathy Hepatorenal syndrome Randomized controlled trial Ascites Portal hypertension Clinical endpoint Placebo Internal medicine Decompensation Esophageal varices Liver disease Gastroenterology Surgery Heart failure Pathology Alternative medicine

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Type: article
Language: en
Landing Page: https://doi.org/10.1186/s13063-024-08063-3
PDF: https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-024-08063-3
OA Status: gold
Cited By: 5
References: 22
Related Works: 10
OpenAlex ID: https://openalex.org/W4394844831

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DOI: https://doi.org/10.1186/s13063-024-08063-3

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Title: Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of oesophageal varices: study protocol for a randomised controlled trial

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Language: en

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Publication year: 2024

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Publication date: 2024-04-16

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Authors: Vishal Patel, Mark McPhail, Ruhama Uddin, Hassan Jafari, Vanessa Lawrence, Clair Le Boutillier, James Shearer, Nahel Yaziji, Angela Cape, Haroon Ahmed, Christopher D. Ward, Peter Walsh, Kevin Besly, Ane Zamalloa, Joanna Kelly, Ashis Mukhopadhya, Alicija Vileito, Tracy Henderson, Gwilym J. Webb, Jerrian Joyce Andrada, Abigail Ford, Cyril Sieberhagen, Claire Burston, Carol Brooks, Gavin Wright, Bushena Miyesa, Aimee Williams, Jay Patel, Melchizedek Penacerrada, Gautham Appanna, Gifthy Perez, Joanne Elliott, Keval Naik, Susan Smolen, Anna Beckwith, Matthew Foxton, Carina Bautista, Matthew Cramp, Ada Laureen Nweze, Gayatri Chakrabarty, Indhuja Rajkumar, Merlin James, Steven Masson, Sheenu Thomas, Lucy Dixon, S. Hogg, Louise Finlay, Kuldeep Cheent, Jessica K. Camp, Adrian J. Stanley, Alexis Duncan, Lauren Walker, Duncan Napier, Paula Hilltout, Linda Hill, Hiromi Uzu, Moby Joseph, Suzannah Pegler, Camille Walling, Lynsey Corless, Anisoara Kingsbury, Tania Nurun, Debasish Das, Anna Williams, Stephen Foley, C W Goodwin, Markus Gess, Margaret Grout, Ka‐Kit Li, Olivia Watchorn, Laura S. Plummer, Laura Blackmore, Christos Tsintikidis, Alexia A. Perryman, G. W. G. Bird, Emily Phiri, Mohamed Saleh, A.O. Woghiren, Dilukshi Wickramasinghe, Jodie Wright, Michael H. Miller, Shona Murray, Leanne Cosgrove, John Hutchinson, Julie Burton, E Stoner, Stephanie Lupton, Mayur Kumar, Nicola Griffiths, Anna Posada, Andrew Fowell, Avisnata Das, Jincy Daniel, Anu Rose Andrews, Dhiraj Tripathi, Emma Burke, E. R. EAVES, H Emms, Dina Mansour, Ann Wilson

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Landing page: https://doi.org/10.1186/s13063-024-08063-3

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Concepts: Medicine, Spontaneous bacterial peritonitis, Carvedilol, Varices, Cirrhosis, Hepatic encephalopathy, Hepatorenal syndrome, Randomized controlled trial, Ascites, Portal hypertension, Clinical endpoint, Placebo, Internal medicine, Decompensation, Esophageal varices, Liver disease, Gastroenterology, Surgery, Heart failure, Pathology, Alternative medicine

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Cited by: 5

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Citations by year (recent): 2025: 3, 2024: 2

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