RecruitingACTRN12626000433303

SAPLING: Observational study of Severe Acute Pancreatitis Looking into ImmuNe siGnatures

Sponsor

University of New South Wales

Enrollment

210 participants

Start Date

Oct 4, 2023

Study Type

Observational

Conditions

Pancreatitis

Summary

Brief description of the study purpose This study aims to better understand how the immune system responds in people with acute pancreatitis (AP), including severe cases that can cause life-threatening organ failure. By comparing patients with pancreatitis to different control groups, researchers hope to identify immune changes that could guide future treatments. Who is it for? You may be eligible if you are a male or female (18 years or older) admitted to hospital with acute pancreatitis, including severe cases requiring intensive care, with pancreatic cancer undergoing surgery, critically ill patients without pancreatic disease, patients with other abdominal conditions, and healthy volunteers. Study details Participants with acute pancreatitis will provide blood samples on several days during their hospital stay (up to Day 28) to assess immune responses over time. Some patients undergoing surgery (for pancreatitis or cancer) may also provide pancreatic tissue samples already being removed as part of their standard treatment. Control group participants will provide blood and/or tissue samples depending on their health condition. All participants will receive standard medical care, and there is no randomisation. Blood and tissue tests will be performed to measure immune markers, cytokines, and other laboratory parameters. It is hoped that this research will improve understanding of how the immune system responds in pancreatitis and related conditions, ultimately guiding new strategies for diagnosis and treatment to improve patient outcomes.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria27

Patients with acute pancreatitis
Patients admitted to hospital aged =/> 18 years old (greater than or equal to 18 years)
A diagnosis of AP requires the presence of at least 2 of the following criteria (based on the Revised 2012 Atlanta Classification and Definitions of Acute Pancreatitis-
Abdominal pain consistent with acute pancreatitis (typically acute onset of a persistent, severe epigastric pain which may radiate to the back)
Biochemical evidence of acute pancreatitis – serum lipase or amylase elevated more than 3 times the upper limit of normal
Characteristic radiological findings of acute pancreatitis
Patients with SAP will be defined as those admitted to the ICU AND with organ failure (as defined by the Modified Marshall Score)
Participant or Person Responsible consent
Patients previously admitted who present with a recurrence of acute pancreatitis (deemed to be a new episode distinct from the previous) will be suitable for inclusion
Control Group 1 (Patients with intra-abdominal malignancy undergoing surgery, including patients with pancreatic cancer)
Tissue control group
Will have some portion of pancreas resected as part of standard treatment (usually as treatment for a tumour)
Age =/> 18 years old (greater than or equal to 18 years)
Participant consent or Person Responsible consent
The pancreatic surgery unit at RNSH has a long history of biobanking both non-neoplastic and neoplastic tissue from patients undergoing surgical resection of pancreatic tumours. Samples from patients who have previously consented for tissue to be biobanked for medical research will be suitable for inclusion.
Control Group 2 (Critically ill patients within the ICU with a generalised inflammatory state (eg. Sepsis, burns) without pancreatic pathology)
For comparison of peripheral blood markers
Age =/> 18 years old (greater than or equal to 18 years)
Participant or Person Responsible consent
Control Group 3 (Healthy volunteers)
For comparison of peripheral blood immunological markers
Age =/> 18 years old (greater than or equal to 18 years)
To be recruited from existing biobank at Kirby Institute
Control Group 4 (Patients with uncomplicated non-pancreatic acute abdominal pathology (diverticulitis, appendicitis, colitis) – all without any evidence of diffuse peritonitis or acute organ failure)
To compare whether patients with uncomplicated acute abdominal pathologies have a different immune endotype to patients with acute pancreatitis
Age =/> 18 years old (greater than or equal to 18 years)
Participant or Person Responsible consent

Exclusion Criteria11

Patients with acute pancreatitis
Patients on long term immunomodulatory therapy
Patients with history of chronic pancreatitis
Patients with history of pancreatic neoplasm
Patients with suspected sepsis at the time of diagnosis of pancreatitis
Control groups
For all control groups, participants with a history of current or prior pancreatitis will be excluded from this study
Participants on long term immunomodulatory therapy will also be excluded
For control group 4, patients thought to have sepsis secondary to their primary abdominal condition will be excluded due to the confounding effects of sepsis on the immune analysis
o For control group 4, patients with acute biliary pathology (eg cholecystitis, choledocolithiasis or cholangitis) will be excluded from this cohort due to the risk of concomitant sepsis or pancreatitis confounding the immune analysis
o The definition of sepsis will be based on the Sepsis 3 definition, which requires the presence of severe infection with associated acute organ dysfunction. For the purpose of the study, any patient in control group 4 who has a suspected infection AND acute organ failure (eg. Acute kidney injury, delirium, neutropaenia or thrombocytopaenia, hypotension requiring vasopressors – causing a SOFA score of 2 or more), will be excluded from the study.

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Interventions

This study will use a convenience sampling strategy. We are targeting a sample of 30 patients with Severe Acute Pancreatitis (SAP) admitted to the ICU for both peripheral blood and tissue (if availab

This study will use a convenience sampling strategy. We are targeting a sample of 30 patients with Severe Acute Pancreatitis (SAP) admitted to the ICU for both peripheral blood and tissue (if available) analysis. Additionally, we aim to recruit 60 patients hospitalized with non-severe Acute Pancreatitis (AP), for peripheral blood analysis. Duration of observation for all participants is 28 days post-recruitment date. Severe Acute Pancreatitis: 30 participants. Blood collected at baseline, day 1, 3, 5, 7, 14 and 28. Acute Pancreatitis: 60. Blood collected at baseline, day 1, 3, 5, 7, 14 and 28.