Pancreatitis, AcuteRESORPNCT03342716
Resolution of Organ Injury in Acute Pancreatitis - RESORP
An observational study of Pancreatitis, Acute, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Acute pancreatitis (AP) is inflammation of the pancreas usually triggered by gallstones or drinking excessive alcohol. 80% of people who have an episode of AP will recover without complications. However, 20% will require treatment in high dependency or intensive care for multiple organ dysfunction (AP-MODS). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pancreatitis, Acute
- How many people
- 229 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Nov 2017to 16 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated at the Royal Infirmary Edinburgh with a clinical or radiological diagnosis of acute pancreatitis.
Who may be able to join
- All patients treated at Royal Infirmary Edinburgh with a clinical or radiological diagnosis of acute pancreatitis will be recruited where possible.
- 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).
- For the radiological diagnosis, if applicable, computerised tomography (CT) and/or ultrasound scan (USS) evidence of acute pancreatitis will be accepted.
Who cannot join
- The following exclusion criteria will be adhered to:
- Patients under the age of 16 years will be excluded from the present study. ii. Prisoners will be excluded from the present study. iii. Patients lacking the capacity to consent will be excluded but can be included if they regain capacity.
- Additional exclusions will apply only to those patients being considered for the nested cohort study:
- Patients not able to undergo MRI scanning for technical reasons will be excluded (e.g. those with cochlear implants, implanted pacemaker) v. Patients with a known allergy to salbutamol
Trial locations and contacts
1 site in 1 country.
About this study
Acute pancreatitis (AP) is inflammation of the pancreas usually triggered by gallstones or drinking excessive alcohol. 80% of people who have an episode of AP will recover without complications. However, 20% will require treatment in high dependency or intensive care for multiple organ dysfunction (AP-MODS). It is known that this negatively affects recovery and can have a lasting effect on health although it is incompletely understood what causes this.
Aim: To recruit 500 patients with acute pancreatitis. Participants will be assessed at recruitment and and again at 3 and 36 months. Recovery of organ function will be serially measured and the presence of novel factors important in recovery assessed.
Read the detailed description
Acute pancreatitis (AP) is a common and devastating disease with an annual incidence of 22-30 per 100,000 in the UK. The incidence is increasing. AP is most commonly triggered by gallstones or alcohol excess and has a range of outcomes, from complete resolution to death, with an overall mortality in Scotland of 5.2%. AP is characterised by acute inflammation of the pancreas, which initiates a cascade of inflammatory events throughout the body that can lead to multiple organ dysfunction syndrome (MODS) in approximately 25% of AP patients. Mortality in AP is greatest in those patients who develop MODS, with death rates reported to be up to 28%.
The development of persistent organ failure characterises severe AP (SAP) as defined in the revised Atlanta classification, and is strongly predictive of a fatal outcome. A significant proportion of research has focussed on reducing mortality and morbidity in the first week. As a consequence, it remains to be seen whether the patterns of early organ dysfunction are reflected in the causes of long-term mortality and morbidity.
Recently published data from a retrospective analysis of patients admitted to the Royal Infirmary of Edinburgh with acute pancreatitis has shown that the early development of MODS is associated with an increased mortality rate up to 10 years after the index presentation. This strongly suggests that MODS in acute pancreatitis (AP-MODS) has a persistent and deleterious impact on patients' physiological status, though the exact nature of this pathology remains to be characterised. Recent data has indicated that the severity of the first attack of AP significantly influences the risk of progression to chronic pancreatitis, and therefore subsequent long-term morbidity.
This observational clinical cohort study aims to characterise the nature and extent of the pathophysiological impact of SAP on organ function over the first 3 years following the index event and the long-term deleterious effect of SAP. This will be achieved by prospectively evaluating the pathophysiological consequences of an episode of AP by measuring organ system function in patients recruited during a hospital admission with AP. We will obtain an in-depth assessment of patients' health at presentation, and at 3 months and 36 months after the first episode of AP using markers of organ function and/or disease in the peripheral blood. In a nested cohort within the main study cohort, we will conduct cardiorespiratory evaluation tests (including exercise testing), specialised blood tests of the immune system, tests for precision medicine, and imaging to assess structure and function of key organ systems.
The results of this study will inform the design of future interventions designed to improve the long-term prognosis of patients.
- Conditions
- Pancreatitis, Acute
- Keywords
- Pancreatitis, Multiple Organ Dysfunction Syndrome
- Medical subject headings
- Pancreatitis, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Main cohort | Patients with a clinical or radiological diagnosis of acute pancreatitis (AP) | |
| Nested cohort | Subgroup of patients with a clinical or radiological diagnosis of acute pancreatitis (AP) who will undergo additional assessments and scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual incidence of new-onset type 3c diabetes mellitis in patients with AP
Do patients that have had AP develop type 3c diabetes mellitis more frequently?
Measured: 66 months
Nested cohort only - difference in the 3 month to 36 month change in pancreatic fibrosis index between participants with AP with MODS and those with AP without MODS
Assess any damage to pancreas at 3 and 36 months and monitor how this changes throughout the course of the trial comparing participants with AP only and those with AP and MODS
Measured: 66 months
Secondary outcomes (6)
Specific gene and promoter sequence variation between participants with AP and AP-MODS
Define any gene and promoter sequence variation between participants with AP and AP-MODS; machine learning approach
Measured: 66 months
miRNA signatures of disease severity and resolution
Comparing patterns of gene expression in mild/moderate/severe cases of AP; machine learning approach
Measured: 66 months
Metabolomic profiling of AP resolution.
Comparing patterns of metabolite expression in mild/moderate/severe cases of AP; machine learning approach
Measured: 66 months
Incidence of premature cellular senescence as a pathological consequence of AP-MODS.
Investigating pathological consequences of AP-MODS compared to AP without MODS
Measured: 66 months
Alteration in immune cell subset phenotype as a long-term response to AP-MODS
Investigating changes to the phenotype of immune cell subsets following an episode of AP; descriptive statistics
Measured: 66 months
Cardiorespiratory dysfunction as a legacy of endothelial injury during AP-MODS
Determination of cardiorespiratory function following AP using physiological measures including cardiopulmonary exercise testing to determine anaerobic threshold. Descriptive measures.
Measured: 66 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start27 Nov 2017
- Primary completion31 Jan 2022
- Study completion16 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatitis, AcuteStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Damian J Mole, MB ChB, Study director, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342716
- Sponsor's protocol ID
- v11 23 Sept 2019
- Other IDs
- MR/P008887/1
- Acronym
- RESORP
- Status last verified
- Feb 2022
- First submitted
- 29 Sep 2017
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sherif AE, McFadyen R, Boyd J, Ventre C, Glenwright M, Walker K, Zheng X, White A, McFadyen L, Connon E, Damaskos D, Steven M, Wackett A, Thomson E, Cameron DC, MacLeod J, Baxter S, Semple S, Morris D, Clark-Stewart S, Graham C, Mole DJ; RESORP research team. Study protocol for resolution of organ injury in acute pancreatitis (RESORP): an observational prospective cohort study. BMJ Open. 2020 Dec 7;10(12):e040200. doi: 10.1136/bmjopen-2020-040200.
PubMed 33293311
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resolution of Organ Injury in Acute Pancreatitis - RESORP
- ClinicalTrials.gov ID
- NCT03342716
- Acronym / sponsor ID
- RESORP / v11 23 Sept 2019
- Conditions
- Pancreatitis, Acute
- Keywords
- Pancreatitis, Multiple Organ Dysfunction Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute pancreatitis (AP) is inflammation of the pancreas usually triggered by gallstones or drinking excessive alcohol. 80% of people who have an episode of AP will recover without complications. However, 20% will require treatment in high dependency or intensive care for multiple organ dysfunction (AP-MODS). It is known that this negatively affects recovery and can have a lasting effect on health although it is incompletely understood what causes this.
Aim: To recruit 500 patients with acute pancreatitis. Participants will be assessed at recruitment and and again at 3 and 36 months. Recovery of organ function will be serially measured and the presence of novel factors important in recovery assessed.
Detailed description
Acute pancreatitis (AP) is a common and devastating disease with an annual incidence of 22-30 per 100,000 in the UK. The incidence is increasing. AP is most commonly triggered by gallstones or alcohol excess and has a range of outcomes, from complete resolution to death, with an overall mortality in Scotland of 5.2%. AP is characterised by acute inflammation of the pancreas, which initiates a cascade of inflammatory events throughout the body that can lead to multiple organ dysfunction syndrome (MODS) in approximately 25% of AP patients. Mortality in AP is greatest in those patients who develop MODS, with death rates reported to be up to 28%.
The development of persistent organ failure characterises severe AP (SAP) as defined in the revised Atlanta classification, and is strongly predictive of a fatal outcome. A significant proportion of research has focussed on reducing mortality and morbidity in the first week. As a consequence, it remains to be seen whether the patterns of early organ dysfunction are reflected in the causes of long-term mortality and morbidity.
Recently published data from a retrospective analysis of patients admitted to the Royal Infirmary of Edinburgh with acute pancreatitis has shown that the early development of MODS is associated with an increased mortality rate up to 10 years after the index presentation. This strongly suggests that MODS in acute pancreatitis (AP-MODS) has a persistent and deleterious impact on patients' physiological status, though the exact nature of this pathology remains to be characterised. Recent data has indicated that the severity of the first attack of AP significantly influences the risk of progression to chronic pancreatitis, and therefore subsequent long-term morbidity.
This observational clinical cohort study aims to characterise the nature and extent of the pathophysiological impact of SAP on organ function over the first 3 years following the index event and the long-term deleterious effect of SAP. This will be achieved by prospectively evaluating the pathophysiological consequences of an episode of AP by measuring organ system function in patients recruited during a hospital admission with AP. We will obtain an in-depth assessment of patients' health at presentation, and at 3 months and 36 months after the first episode of AP using markers of organ function and/or disease in the peripheral blood. In a nested cohort within the main study cohort, we will conduct cardiorespiratory evaluation tests (including exercise testing), specialised blood tests of the immune system, tests for precision medicine, and imaging to assess structure and function of key organ systems.
The results of this study will inform the design of future interventions designed to improve the long-term prognosis of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main cohort | – | –Patients with a clinical or radiological diagnosis of acute pancreatitis (AP) |
| Nested cohort | – | –Subgroup of patients with a clinical or radiological diagnosis of acute pancreatitis (AP) who will undergo additional assessments and scans |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated at the Royal Infirmary Edinburgh with a clinical or radiological diagnosis of acute pancreatitis.
Key inclusion criteria (3 listed)
- All patients treated at Royal Infirmary Edinburgh with a clinical or radiological diagnosis of acute pancreatitis will be recruited where possible.
- 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).
- For the radiological diagnosis, if applicable, computerised tomography (CT) and/or ultrasound scan (USS) evidence of acute pancreatitis will be accepted.
Key exclusion criteria (4 listed)
- Patients under the age of 16 years will be excluded from the present study. ii. Prisoners will be excluded from the present study. iii. Patients lacking the capacity to consent will be excluded but can be included if they regain capacity.
- Additional exclusions will apply only to those patients being considered for the nested cohort study:
- Patients not able to undergo MRI scanning for technical reasons will be excluded (e.g. those with cochlear implants, implanted pacemaker) v. Patients with a known allergy to salbutamol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Annual incidence of new-onset type 3c diabetes mellitis in patients with AP
Time frame: 66 months
Do patients that have had AP develop type 3c diabetes mellitis more frequently?
Nested cohort only - difference in the 3 month to 36 month change in pancreatic fibrosis index between participants with AP with MODS and those with AP without MODS
Time frame: 66 months
Assess any damage to pancreas at 3 and 36 months and monitor how this changes throughout the course of the trial comparing participants with AP only and those with AP and MODS
6 secondary outcomes
Specific gene and promoter sequence variation between participants with AP and AP-MODS
Time frame: 66 months
miRNA signatures of disease severity and resolution
Time frame: 66 months
Metabolomic profiling of AP resolution.
Time frame: 66 months
Incidence of premature cellular senescence as a pathological consequence of AP-MODS.
Time frame: 66 months
Alteration in immune cell subset phenotype as a long-term response to AP-MODS
Time frame: 66 months
Cardiorespiratory dysfunction as a legacy of endothelial injury during AP-MODS
Time frame: 66 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Derived from this study: PubMed 33293311Sherif AE, McFadyen R, Boyd J, Ventre C, Glenwright M, Walker K, Zheng X, White A, McFadyen L, Connon E, Damaskos D, Steven M, Wackett A, Thomson E, Cameron DC, MacLeod J, Baxter S, Semple S, Morris D, Clark-Stewart S, Graham C, Mole DJ; RESORP research team. Study protocol for resolution of organ injury in acute pancreatitis (RESORP): an observational prospective cohort study. BMJ Open. 2020 Dec 7;10(12):e040200. doi: 10.1136/bmjopen-2020-040200.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damian J Mole, MB ChB study director
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis, Acute, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual incidence of new-onset type 3c diabetes mellitis in patients with AP (time frame: 66 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03342716, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.