Study protocol for resolution of organ injury in acute pancreatitis (RESORP): an observational prospective cohort study

• Main Authors: Ahmed E Sherif, Rory McFadyen, Julia Boyd, Margaret Glenwright, Xiaozhong Zheng, Laura McFadyen, Emma Connon, Michelle Steven, Anthony Wackett, Euan Thomson, David C Cameron, Shaun Baxter, Saskia Clark-Stewart
• Format: Article
• Language: English
• Published: BMJ Publishing Group 2020-12-01
• Series: BMJ Open
• Online Access: https://bmjopen.bmj.com/content/10/12/e040200.full

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.