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

Ahmed E Sherif, Rory McFadyen, Julia Boyd, Chiara Ventre, Margaret Glenwright, Kim Walker, Xiaozhong Zheng, Audrey White, Laura McFadyen, Emma Connon, Dimitrios Damaskos, Michelle Steven, Anthony Wackett, Euan Thomson, David C Cameron, Jill MacLeod, Shaun Baxter, Scott Semple, David Morris, Saskia Clark-Stewart, Catriona Graham, Damian J Mole, RESORP research team, Ahmed E Sherif, Rory McFadyen, Julia Boyd, Chiara Ventre, Margaret Glenwright, Kim Walker, Xiaozhong Zheng, Audrey White, Laura McFadyen, Emma Connon, Dimitrios Damaskos, Michelle Steven, Anthony Wackett, Euan Thomson, David C Cameron, Jill MacLeod, Shaun Baxter, Scott Semple, David Morris, Saskia Clark-Stewart, Catriona Graham, Damian J Mole, RESORP research team

Abstract

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.

Keywords: adult intensive & critical care; general diabetes; pancreatic disease.

Conflict of interest statement

Competing interests: DJM wishes to declare that he holds a senior position in a private company developing medicines for systemic inflammation and cancer, and that he has previously received funding for collaborative studies on AP from GSK.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

References

    1. Yadav D, Lowenfels AB. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology 2013;144:1252–61. 10.1053/j.gastro.2013.01.068
    1. Banks PA. Epidemiology, natural history, and predictors of disease outcome in acute and chronic pancreatitis. Gastrointest Endosc 2002;56:S226–30. 10.1016/S0016-5107(02)70016-3
    1. Lankisch PG, Apte M, Banks PA. Acute pancreatitis. Lancet 2015;386:85–96. 10.1016/S0140-6736(14)60649-8
    1. McKay CJ, Evans S, Sinclair M, et al. . High early mortality rate from acute pancreatitis in Scotland, 1984-1995. Br J Surg 1999;86:1302–5. 10.1046/j.1365-2168.1999.01246.x
    1. Roberts SE, Williams JG, Meddings D, et al. . Incidence and case fatality for acute pancreatitis in England: geographical variation, social deprivation, alcohol consumption and aetiology--a record linkage study. Aliment Pharmacol Ther 2008;28:931–41. 10.1111/j.1365-2036.2008.03809.x
    1. Skouras C, Hayes AJ, Williams L, et al. . Early organ dysfunction affects long-term survival in acute pancreatitis patients. HPB 2014;16:789–96. 10.1111/hpb.12259
    1. Mole DJ, Gungabissoon U, Johnston P, et al. . Identifying risk factors for progression to critical care admission and death among individuals with acute pancreatitis: a record linkage analysis of Scottish healthcare databases. BMJ Open 2016;6:e011474. 10.1136/bmjopen-2016-011474
    1. Dellinger EP, Forsmark CE, Layer P, et al. . Determinant-Based classification of acute pancreatitis severity: an international multidisciplinary consultation. Ann Surg 2012;256:875–80. 10.1097/SLA.0b013e318256f778
    1. Banks PA, Bollen TL, Dervenis C, et al. . Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut 2013;62:102–11. 10.1136/gutjnl-2012-302779
    1. Johnson CD, Abu-Hilal M. Persistent organ failure during the first week as a marker of fatal outcome in acute pancreatitis. Gut 2004;53:1340–4. 10.1136/gut.2004.039883
    1. Garg PK, Singh VP. Organ failure due to systemic injury in acute pancreatitis. Gastroenterology 2019;156:2008–23. 10.1053/j.gastro.2018.12.041
    1. Neyton LPA, Zheng X, Skouras C, Doeschl-Wilson A, et al. . Molecular patterns in acute pancreatitis reflect generalizable Endotypes of the host response to systemic injury in humans. Ann Surg 10.1097/SLA.0000000000003974
    1. Nøjgaard C. Prognosis of acute and chronic pancreatitis - a 30-year follow-up of a Danish cohort. Dan Med Bull 2010;57:B4228.
    1. Lankisch PG, Breuer N, Bruns A, et al. . Natural history of acute pancreatitis: a long-term population-based study. Am J Gastroenterol 2009;104:2797–805. 10.1038/ajg.2009.405
    1. Cavestro GM, Leandro G, Di Leo M, et al. . A single-centre prospective, cohort study of the natural history of acute pancreatitis. Dig Liver Dis 2015;47:205–10. 10.1016/j.dld.2014.11.003
    1. Appelros S, Lindgren S, Borgström A. Short and long term outcome of severe acute pancreatitis. Eur J Surg 2001;167:281–6. 10.1080/110241501300091462
    1. Halonen KI, Pettilä V, Leppäniemi AK, et al. . Long-Term health-related quality of life in survivors of severe acute pancreatitis. Intensive Care Med 2003;29:782–6. 10.1007/s00134-003-1700-8
    1. Ciesla N, Dinglas V, Fan E, et al. . Manual muscle testing: a method of measuring extremity muscle strength applied to critically ill patients. J Vis Exp 2011;50:e2632. 10.3791/2632
    1. Sway medical Sway balance 2020, 2020. Available: [Accessed 20 Feb 2020].
    1. Amick RZ, Chaparro A, Patterson JA. Test-Retest reliability of the sway balance mobile application. J Mob Technol Med 2015;4:40–7. 10.7309/jmtm.4.2.6
    1. Pulmonary Rehabilitation Six-minute walk test, 2020. Available: [Accessed 20 Feb 2020].
    1. Guidelines for the measurement of respiratory function. recommendations of the British thoracic Society and the association of respiratory technicians and Physiologists. Respir Med 1994;88:165–94.
    1. W K, JE H, DY S, et al. . Principles of exercise testing and interpretation. Philadelphia, PA: Lippincott Williams & Wilkins, 2005: 133–56.
    1. American Thoracic Society, American College of Chest Physicians . ATS/ACCP statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med 2003;167:211–77. 10.1164/rccm.167.2.211
    1. Ewald N, Kaufmann C, Raspe A, et al. . Prevalence of diabetes mellitus secondary to pancreatic diseases (type 3C). Diabetes Metab Res Rev 2012;28:338–42. 10.1002/dmrr.2260
    1. Woodmansey C, McGovern AP, McCullough KA, et al. . Incidence, demographics, and clinical characteristics of diabetes of the exocrine pancreas (type 3C): a retrospective cohort study. Diabetes Care 2017;40:1486–93. 10.2337/dc17-0542
    1. Banerjee R, Pavlides M, Tunnicliffe EM, et al. . Multiparametric magnetic resonance for the non-invasive diagnosis of liver disease. J Hepatol 2014;60:69–77. 10.1016/j.jhep.2013.09.002
    1. Harris PA, Taylor R, Minor BL, et al. . The REDCap Consortium: building an international community of software platform partners. J Biomed Inform 2019;95:103208. 10.1016/j.jbi.2019.103208
    1. Harris PA, Taylor R, Thielke R, et al. . Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81. 10.1016/j.jbi.2008.08.010
    1. Lin K, Watkins B, Johnson T, et al. . Screening for chronic obstructive pulmonary disease using spirometry: summary of the evidence for the U.S. preventive services Task force. Ann Intern Med 2008;148:535–43. 10.7326/0003-4819-148-7-200804010-00213
    1. Buist AS, Vollmer WM, Sullivan SD, et al. . The burden of obstructive lung disease initiative (BOLD): rationale and design. COPD 2005;2:277–83. 10.1081/COPD-57610
    1. Coates AL, Graham BL, McFadden RG, et al. . Spirometry in primary care. Can Respir J 2013;20:13–22. 10.1155/2013/615281
    1. Dill T. Contraindications to magnetic resonance imaging: non-invasive imaging. Heart 2008;94:943–8. 10.1136/hrt.2007.125039

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅