Resolution of Organ Injury in Acute Pancreatitis - RESORP

NCT03342716 | Completed

• 2 other identifiers: v11 23 Sept 2019MR/P008887/1
• Study Type: observational
• Target: 229
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Pancreatitis, Acute

Keywords

Pancreatitis; Multiple Organ Dysfunction Syndrome

Outcome Measures

Primary Outcomes (2)

• 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?

  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

  66 months

Secondary Outcomes (6)

• Specific gene and promoter sequence variation between participants with AP and AP-MODS

  66 months

• miRNA signatures of disease severity and resolution

  66 months

• Metabolomic profiling of AP resolution.

  66 months

• Incidence of premature cellular senescence as a pathological consequence of AP-MODS.

  66 months

• Alteration in immune cell subset phenotype as a long-term response to AP-MODS

  66 months

Study Arms (2)

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated at the Royal Infirmary Edinburgh with a clinical or radiological diagnosis of acute pancreatitis.

You may qualify if:

• 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.

You may not qualify if:

• i. 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.
• iv. 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

Sponsors & Collaborators

• University of Edinburgh: lead
• Medical Research Council: collaborator

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33293311 DERIVED

Related Links

• Protocol publication

Biospecimen

Retention: SAMPLES WITH DNA

Both DNA and RNA samples taken at baseline, 3 and 36 month visits

MeSH Terms

Conditions

Pancreatitis; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Damian J Mole, MB ChB

  University of Edinburgh

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: November 17, 2017
• Study Start: November 27, 2017
• Primary Completion: January 31, 2022
• Study Completion: February 16, 2022
• Last Updated: March 28, 2022

Record last verified: 2022-02

Locations

GB (1)