Resolution of organ injury in acute pancreatitis
| ISRCTN | ISRCTN50581876 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50581876 |
| ClinicalTrials.gov number | NCT03342716 |
| Secondary identifying numbers | v8 01 Dec 2017 |
- Submission date
- 08/11/2017
- Registration date
- 13/11/2017
- Last edited
- 15/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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 March 2022
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Prof Damian Mole
Contact information
Scientific
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
Study information
| Study design | Observational cohort study with a nested cohort |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Resolution of Organ Injury in Acute Pancreatitis (RESORP): an observational cohort study with a nested cohort |
| Study acronym | RESORP |
| Study objectives | To define long-term organ hypofunction after an episode of acute pancreatitis. |
| Ethics approval(s) | South East Scotland Research Ethics Committee 01, 15/04/2016, REC ref: 16/SS/0065 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2015 |
| Completion date | 31/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 500 |
| Total final enrolment | 229 |
| Key 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 |
| Key exclusion criteria | Current exclusion criteria as of 09/04/2024: 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 during the hospital admission 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 (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 |
| Date of first enrolment | 27/11/2017 |
| Date of final enrolment | 12/03/2020 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centres
Edinburgh
EH16 4SA
United Kingdom
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Sponsor information
University/education
The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Website | http://www.accord.ed.ac.uk |
|---|
Hospital/treatment centre
The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 07/12/2020 | 10/03/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
15/04/2024: The intention to publish date was changed from 31/07/2024 to 31/07/2026.
09/04/2024: The following changes were made to the trial record:
1. A contact was removed.
2. The exclusion criteria were changed.
3. The intention to publish date was changed from 31/01/2024 to 31/07/2024.
4. The plain English summary was updated to reflect these changes.
12/09/2023: The intention to publish date was changed from 30/09/2023 to 31/01/2024.
23/03/2023: The intention to publish date was changed from 31/03/2023 to 30/09/2023.
10/03/2022: The following changes have been made:
1. Publication reference added.
2. The trial website has been added.
21/02/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/05/2020 to 12/03/2020.
2. The overall end date was changed from 31/03/2023 to 31/03/2022.
3. The intention to publish date was changed from 31/07/2023 to 31/03/2023.
4. Total final enrolment added.
12/06/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 27/05/2020 to 31/05/2020.
2. The overall end date was changed from 31/07/2022 to 31/03/2023.
3. The plain English summary was updated to reflect these changes.
18/12/2017: The following changes were made:
1. The protocol/serial number was changed from v7 23 Aug 2017 to v8 01 Dec 2017
2. The overall trial start date was changed from 02/10/2016 to 01/09/2015.
3. The recruitment start date was changed from 20/11/2017 to 27/11/2017.
4. The recruitment end date was changed from 19/05/2020 to 27/05/2020.
5. Participant exclusion criteria and contact address were updated.
6. ORCID ID and ClinicalTrials.gov number were added.
