Plain English Summary
Background and study aims
Acute pancreatitis is inflammation of the pancreas, usually triggered by gallstones or excess alcohol use. At the moment, the medium to long-term effects of pancreatitis on individual organ systems are not known (e.g. the lungs and kidneys). It is known that people who have a severe attack of pancreatitis have a shorter overall life expectancy than those who have a mild attack. Because the cells in the body that produce insulin are located in the pancreas, when the pancreas gets damaged by inflammation, some people lose the function of their insulin-producing cells and can become diabetic. The aim of this study is to assess long-term organ function after an episode of acute pancreatitis.
Who can participate?
Patients aged over 16 with acute pancreatitis treated at Royal Infirmary Edinburgh
What does the study involve?
Participants have their overall health and specific organ function assessed at the time of their acute episode, 3 months afterwards, and again 2 years after that. Additional heart and lung tests, blood tests of the immune system, and imaging to assess structure and function of key organ systems are also conducted in some of the participants.
What are the possible benefits and risks of participating?
This study will help with understanding what the long-term negative effects of an episode of pancreatitis are. Although no new treatments are tested in this study, the results may lead to the development of better ways of caring for people who have had an episode of acute pancreatitis. There are no direct benefits to individual participants as individual study data is not shared with participants, and there is no treatment or alteration of standard care for participants. With regard to risks, these are minimal, and are associated with blood sampling.
Where is the study run from?
1. Royal Infirmary Edinburgh (UK)
2. Wellcome Trust Clinical Research Facility (UK)
When is the study starting and how long is it expected to run for?
September 2015 to July 2022
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
1. Dr Damian Mole
2. Dr Julia Boyd
Trial website
Contact information
Type
Scientific
Primary contact
Dr Damian Mole
ORCID ID
Contact details
MRC Centre for Inflammation Research (W2.16)
Queen’s Medical Research Institute
The University of Edinburgh
47 Little France Crescent
Edinburgh
EH16 4JT
United Kingdom
Type
Scientific
Additional contact
Dr Julia Boyd
ORCID ID
http://orcid.org/0000-0002-9872-3893
Contact details
Edinburgh Clinical Trials Unit (ECTU)
Usher Institute
University of Edinburgh
Nine Bioquarter
9 Little France Road
Edinburgh
EH16 4UX
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT03342716
Protocol/serial number
v8 01 Dec 2017
Study information
Scientific title
Resolution of Organ Injury in Acute Pancreatitis (RESORP): an observational cohort study with a nested cohort
Acronym
RESORP
Study hypothesis
To define long-term organ hypofunction after an episode of acute pancreatitis.
Ethics approval
South East Scotland Research Ethics Committee 01, 15/04/2016, REC ref: 16/SS/0065
Study design
Observational cohort study with a nested cohort
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Acute pancreatitis
Intervention
The cohort assessment will comprise of 3 study visits. In-depth assessments of a participant’s health at presentation, at 3 months and at 27 months after the first episode of acute pancreatitis will be obtained. Additional cardiorespiratory evaluation tests, specialised blood tests of the immune system, tests for precision medicine, and imaging to assess structure and function of key organ systems will be conducted in a nested cohort of participants.
For the whole cohort (estimated 500 individuals, each tested three times (at recruitment, 3 months and 27 months after AP):
1. Full peripheral venous blood profiling, including cardiac biomarkers, standard biochemistry profiling, and samples retained for miRNA profiling, cytokines, telomere length, metabolomic profiling, proteomic profiling, transcriptomic profiling, genomic profiling, leukocyte subset analysis by flow cytometry
2. Biochemical markers of organ function in urine and samples retained
3. Pancreatic exocrine function test in stool (faecal elastase) and samples retained
4. Nutritional assessment
5. Oral glucose tolerance test at 3 and 27-month follow-up visit (measure random glucose level only in insulin dependent diabetics)
6. 12-lead electrocardiogram (ECG), blood pressure
7. Peripheral SpO2
8. Sway balance app, non-invasive muscle function tests
9. Self-administered Patient Questionnaire:
9.1. Gastrointestinal Quality of Life Index (GIQLI)
9.2. SF-12 Quality of Life
9.3. Montreal Cognitive Assessment
Intervention type
Other
Phase
Drug names
Primary outcome measures
The incidence of new onset type 3c diabetes mellitus in patients with AP measured at 27 months, compared to the age matched population of Scotland
Secondary outcome measures
Full peripheral venous blood profiling, including cardiac biomarkers, standard biochemistry profiling, and samples retained for miRNA profiling, cytokines, telomere length, metabolomic profiling, proteomic profiling, transcriptomic profiling, genomic profiling, leukocyte subset analysis by flow cytometry, at recruitment, 3 months and 27 months after AP
Overall trial start date
01/09/2015
Overall trial end date
31/07/2022
Reason abandoned
Eligibility
Participant inclusion criteria
1. All patients treated at Royal Infirmary Edinburgh with a clinical or radiological diagnosis of acute pancreatitis will be recruited where possible
2. For the potential clinical diagnosis of acute pancreatitis an appropriate clinical history based on compatible clinical features, will be required (i.e. abdominal pain, nausea and/or vomiting), supported by the finding of elevated serum amylase greater than 3x the upper limit of the reference range for the laboratory (currently 300 U/L)
3. For the radiological diagnosis, if applicable, computerised tomography (CT) and/or ultrasound scan (USS) evidence of acute pancreatitis will be accepted
4. With the exception of prisoners, all adult patients with capacity to give informed consent will be considered
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Participant exclusion criteria
Current Participant exclusion criteria (as of 18/12/2017):
1. Patients under the age of 16 years will be excluded from the present study
2. Prisoners will be excluded from the present study
3. Patients lacking the capacity to consent will be excluded but can be included if they regain capacity
The additional two exclusions below apply only to those patients being considered for the nested cohort study:
4. Patients not able to undergo MRI scanning for technical reasons will be excluded (e.g. those with cochlear implants, implanted pacemaker)
5. Patients with a known allergy to salbutamol
Previous Participant exclusion criteria:
1. Patients under the age of 16 years will be excluded from the present study
2. Prisoners will be excluded from the present study
3. Patients lacking the capacity to consent will be excluded but can be included if they regain capacity
4. Patients not able to undergo MRI scanning for technical reasons will be excluded (e.g. those with cochlear implants, implanted pacemaker)
5. An additional exclusion will apply only to those patients being considered for the nested cohort study: patients with a known allergy to salbutamol
Recruitment start date
27/11/2017
Recruitment end date
27/05/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Infirmary Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Trial participating centre
Wellcome Trust Clinical Research Facility
Royal Infirmary Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Sponsor information
Organisation
The University of Edinburgh
Sponsor details
The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
Sponsor type
University/education
Website
Organisation
NHS Lothian
Sponsor details
The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research council
Funder name
Medical Research Council
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The intention is to publish the protocol and supporting material in the scientific literature and this will be made available online in due course. Planned publication of the results in a high-impact peer reviewed journal.
IPD sharing plan
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/07/2023
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary