Cargando…
Study protocol for resolution of organ injury in acute pancreatitis (RESORP): an observational prospective cohort study
INTRODUCTION: Survivors of acute pancreatitis (AP) have shorter overall survival and increased incidence of new-onset cardiovascular, respiratory, liver and renal disease, diabetes mellitus and cancer compared with the general population, but the mechanisms that explain this are yet to be elucidated...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7722833/ https://www.ncbi.nlm.nih.gov/pubmed/33293311 http://dx.doi.org/10.1136/bmjopen-2020-040200 |
_version_ | 1783620230900088832 |
---|---|
author | Sherif, Ahmed E McFadyen, Rory Boyd, Julia Ventre, Chiara Glenwright, Margaret Walker, Kim Zheng, Xiaozhong White, Audrey McFadyen, Laura Connon, Emma Damaskos, Dimitrios Steven, Michelle Wackett, Anthony Thomson, Euan Cameron, David C MacLeod, Jill Baxter, Shaun Semple, Scott Morris, David Clark-Stewart, Saskia Graham, Catriona Mole, Damian J |
author_facet | Sherif, Ahmed E McFadyen, Rory Boyd, Julia Ventre, Chiara Glenwright, Margaret Walker, Kim Zheng, Xiaozhong White, Audrey McFadyen, Laura Connon, Emma Damaskos, Dimitrios Steven, Michelle Wackett, Anthony Thomson, Euan Cameron, David C MacLeod, Jill Baxter, Shaun Semple, Scott Morris, David Clark-Stewart, Saskia Graham, Catriona Mole, Damian J |
author_sort | Sherif, Ahmed E |
collection | PubMed |
description | INTRODUCTION: Survivors of acute pancreatitis (AP) have shorter overall survival and increased incidence of new-onset cardiovascular, respiratory, liver and renal disease, diabetes mellitus and cancer compared with the general population, but the mechanisms that explain this are yet to be elucidated. Our aim is to characterise the precise nature and extent of organ dysfunction following an episode of AP. METHODS AND ANALYSIS: This is an observational prospective cohort study in a single centre comprising a University hospital with an acute and emergency receiving unit and clinical research facility. Participants will be adult patient admitted with AP. Participants will undergo assessment at recruitment, 3 months and 3 years. At each time point, multiple biochemical and/or physiological assessments to measure cardiovascular, respiratory, liver, renal and cognitive function, diabetes mellitus and quality of life. Recruitment was from 30 November 2017 to 31 May 2020; last follow-up measurements is due on 31 May 2023. The primary outcome measure is the incidence of new-onset type 3c diabetes mellitus during follow-up. Secondary outcome measures include: quality of life analyses (SF-36, Gastrointestinal Quality of Life Index); montreal cognitive assessment; organ system physiological performance; multiomics predictors of AP severity, detection of premature cellular senescence. In a nested cohort within the main cohort, individuals may also consent to multiparameter MRI scan, echocardiography, pulmonary function testing, cardiopulmonary exercise testing and pulse-wave analysis. ETHICS AND DISSEMINATION: This study has received the following approvals: UK IRAS Number 178615; South-east Scotland Research Ethics Committee number 16/SS/0065. Results will be made available to AP survivors, caregivers, funders and other researchers. Publications will be open-access. TRIAL REGISTRATION NUMBERS: ClinicalTrials.gov Registry (NCT03342716) and ISRCTN50581876; Pre-results. |
format | Online Article Text |
id | pubmed-7722833 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-77228332020-12-14 Study protocol for resolution of organ injury in acute pancreatitis (RESORP): an observational prospective cohort study Sherif, Ahmed E McFadyen, Rory Boyd, Julia Ventre, Chiara Glenwright, Margaret Walker, Kim Zheng, Xiaozhong White, Audrey McFadyen, Laura Connon, Emma Damaskos, Dimitrios Steven, Michelle Wackett, Anthony Thomson, Euan Cameron, David C MacLeod, Jill Baxter, Shaun Semple, Scott Morris, David Clark-Stewart, Saskia Graham, Catriona Mole, Damian J BMJ Open Surgery INTRODUCTION: Survivors of acute pancreatitis (AP) have shorter overall survival and increased incidence of new-onset cardiovascular, respiratory, liver and renal disease, diabetes mellitus and cancer compared with the general population, but the mechanisms that explain this are yet to be elucidated. Our aim is to characterise the precise nature and extent of organ dysfunction following an episode of AP. METHODS AND ANALYSIS: This is an observational prospective cohort study in a single centre comprising a University hospital with an acute and emergency receiving unit and clinical research facility. Participants will be adult patient admitted with AP. Participants will undergo assessment at recruitment, 3 months and 3 years. At each time point, multiple biochemical and/or physiological assessments to measure cardiovascular, respiratory, liver, renal and cognitive function, diabetes mellitus and quality of life. Recruitment was from 30 November 2017 to 31 May 2020; last follow-up measurements is due on 31 May 2023. The primary outcome measure is the incidence of new-onset type 3c diabetes mellitus during follow-up. Secondary outcome measures include: quality of life analyses (SF-36, Gastrointestinal Quality of Life Index); montreal cognitive assessment; organ system physiological performance; multiomics predictors of AP severity, detection of premature cellular senescence. In a nested cohort within the main cohort, individuals may also consent to multiparameter MRI scan, echocardiography, pulmonary function testing, cardiopulmonary exercise testing and pulse-wave analysis. ETHICS AND DISSEMINATION: This study has received the following approvals: UK IRAS Number 178615; South-east Scotland Research Ethics Committee number 16/SS/0065. Results will be made available to AP survivors, caregivers, funders and other researchers. Publications will be open-access. TRIAL REGISTRATION NUMBERS: ClinicalTrials.gov Registry (NCT03342716) and ISRCTN50581876; Pre-results. BMJ Publishing Group 2020-12-07 /pmc/articles/PMC7722833/ /pubmed/33293311 http://dx.doi.org/10.1136/bmjopen-2020-040200 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Surgery Sherif, Ahmed E McFadyen, Rory Boyd, Julia Ventre, Chiara Glenwright, Margaret Walker, Kim Zheng, Xiaozhong White, Audrey McFadyen, Laura Connon, Emma Damaskos, Dimitrios Steven, Michelle Wackett, Anthony Thomson, Euan Cameron, David C MacLeod, Jill Baxter, Shaun Semple, Scott Morris, David Clark-Stewart, Saskia Graham, Catriona Mole, Damian J Study protocol for resolution of organ injury in acute pancreatitis (RESORP): an observational prospective cohort study |
title | Study protocol for resolution of organ injury in acute pancreatitis (RESORP): an observational prospective cohort study |
title_full | Study protocol for resolution of organ injury in acute pancreatitis (RESORP): an observational prospective cohort study |
title_fullStr | Study protocol for resolution of organ injury in acute pancreatitis (RESORP): an observational prospective cohort study |
title_full_unstemmed | Study protocol for resolution of organ injury in acute pancreatitis (RESORP): an observational prospective cohort study |
title_short | Study protocol for resolution of organ injury in acute pancreatitis (RESORP): an observational prospective cohort study |
title_sort | study protocol for resolution of organ injury in acute pancreatitis (resorp): an observational prospective cohort study |
topic | Surgery |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7722833/ https://www.ncbi.nlm.nih.gov/pubmed/33293311 http://dx.doi.org/10.1136/bmjopen-2020-040200 |
work_keys_str_mv | AT sherifahmede studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT mcfadyenrory studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT boydjulia studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT ventrechiara studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT glenwrightmargaret studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT walkerkim studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT zhengxiaozhong studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT whiteaudrey studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT mcfadyenlaura studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT connonemma studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT damaskosdimitrios studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT stevenmichelle studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT wackettanthony studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT thomsoneuan studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT camerondavidc studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT macleodjill studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT baxtershaun studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT semplescott studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT morrisdavid studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT clarkstewartsaskia studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT grahamcatriona studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT moledamianj studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy AT studyprotocolforresolutionoforganinjuryinacutepancreatitisresorpanobservationalprospectivecohortstudy |