Condition category
Digestive System
Date applied
08/11/2017
Date assigned
13/11/2017
Last edited
18/12/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.accord.ed.ac.uk

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

Publication citations

Additional files

Editorial Notes

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.