ERCP-induced and Non-ERCP Induced Acute Pancreatitis: Two Distinct Clinical and Immunological Entities?

NCT02602574 | Unknown DMC

• 1 other identifier: PEP 2015
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Post endoscopic pancreatitis (PEP) has different initial immunologic response to primary injury compared to acute pancreatitis of other etiology (non-PEP AP). The purpose of this study is to compare initial immunologic response, 24 h after primary injury, in patients with PEP and patients with acute pancreatitis of other etiology.

Conditions

Post-ERCP Acute Pancreatitis

Keywords

Cholangiopancreatography, Endoscopic Retrograde; Pancreatitis; Heat-Shock Proteins; Pentraxin 3 protein; C-Reactive Protein; procalcitonin; Interleukin-1 beta; Leukocytes, Mononuclear; Killer Cells, Natural; natural-killer group 2, member D receptor

Outcome Measures

Primary Outcomes (1)

• Evaluation of initial immunologic response in patients with PEP and patients with AP of other etiology (Number of Participants With Abnormal Laboratory Values)

  Number of Participants With Abnormal Laboratory Values

  24 hours after the primary injury

Secondary Outcomes (1)

• Correlation between differences in initial inflammatory response and clinical outcomes of AP (biliary and alcoholic) and PEP (Number of Participants With Abnormal Laboratory Values)

  1 month

Study Arms (3)

ERCP- induced acute pancreatitis

All patients with indication for ERCP will be prepared for ERCP. One hour before and 4-6 hours after the procedure 10 mL of blood sample and urine sample will be collected. 24 hours after the procedure all patients will be taken 30 ml of heparinized peripheral venous blood and urine sample. Upon clinical and laboratory confirmation of acute pancreatitis according to ESGE guidelines for post-ERCP pancreatitis, will be further monitored during hospitalization for evaluation of the severity of the disease.

Other: heparinized peripheral venous blood and urine sample.

non -ERCP acute pancreatitis

All patients with acute pancreatitis according to Atlanta criteria admitted through Emergency Department will be taken 30 ml of heparinized peripheral venous blood and urine sample upon 24 hours after the clinical symptoms have started. 10 mL of collected blood samples will be examined in the Department of Laboratory Medicine. Other 20 mL of blood samples will be sent to Department of Physiology and Immunology, School of Medicine where immunologic analysis will be performed. This group of patients will be further monitored during hospitalization for evaluation of the severity of the disease. Severity of the disease will be assessed according to the Atlanta criteria.

Other: heparinized peripheral venous blood and urine sample.

Control group

Control group will consist of patients who underwent ERCP but didn't develop acute pancreatitis. One hour before and 4-6 hours after the procedure 10 mL of blood sample and urine sample will be collected. 24 hours after the procedure all patients will be taken 30 ml of heparinized peripheral venous blood and urine sample.

Other: heparinized peripheral venous blood and urine sample.

Interventions

heparinized peripheral venous blood and urine sample. OTHER

All patients will be taken heparinized peripheral venous blood and urine sample

Control group; ERCP- induced acute pancreatitis; non -ERCP acute pancreatitis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with indication for ERCP and all patients with acute pancreatitis admitted through Emergency Department

You may qualify if:

• all patients underwent to ERCP irrespectively about the diagnosis
• all patients with diagnosed acute pancreatitis according to Atlanta criteria admitted through Emergency Department within 24 hours of onset of symptoms.

You may not qualify if:

• unwillingness or inability to consent for the study
• anticipated inability to follow protocol, previous ERCP, acute cholecystitis and/or cholangitis
• active or recent (within 4 weeks) gastrointestinal hemorrhage
• existing acute pancreatitis (lipase peak) within 72 hours prior to ERCP
• intrauterine pregnancy, breast feeding mother
• patients with chronic inflammatory diseases (e.g. IBD) systemic inflammatory and autoimmune disorders (e.g. systemic lupus erythematosus, ) or acute inflammatory diseases (e.g. pneumonia, pyelonephritis or sepsis of any cause)
• patients on immunomodulatory or immunosuppressive therapy.

Sponsors & Collaborators

• University Hospital Rijeka: lead

Study Sites (1)

Clinical Hospital Centre

Rijeka, Kresimirova 42, 51000, Croatia

Location

Related Publications (8)

• Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.

  PMID: 23100216 BACKGROUND

• Yadav D, Lowenfels AB. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology. 2013 Jun;144(6):1252-61. doi: 10.1053/j.gastro.2013.01.068.

  PMID: 23622135 BACKGROUND

• Dumonceau JM, Andriulli A, Elmunzer BJ, Mariani A, Meister T, Deviere J, Marek T, Baron TH, Hassan C, Testoni PA, Kapral C; European Society of Gastrointestinal Endoscopy. Prophylaxis of post-ERCP pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - updated June 2014. Endoscopy. 2014 Sep;46(9):799-815. doi: 10.1055/s-0034-1377875. Epub 2014 Aug 22.

  PMID: 25148137 BACKGROUND

• Kylanpaa L, Rakonczay Z Jr, O'Reilly DA. The clinical course of acute pancreatitis and the inflammatory mediators that drive it. Int J Inflam. 2012;2012:360685. doi: 10.1155/2012/360685. Epub 2012 Dec 12.

  PMID: 23304633 BACKGROUND

• Demols A, Deviere J. New frontiers in the pharmacological prevention of post-ERCP pancreatitis: the cytokines. JOP. 2003 Jan;4(1):49-57.

  PMID: 12555016 BACKGROUND

• Testoni PA, Vailati C, Giussani A, Notaristefano C, Mariani A. ERCP-induced and non-ERCP-induced acute pancreatitis: Two distinct clinical entities with different outcomes in mild and severe form? Dig Liver Dis. 2010 Aug;42(8):567-70. doi: 10.1016/j.dld.2009.10.008. Epub 2009 Dec 16.

  PMID: 20018574 BACKGROUND

• Fung AS, Tsiotos GG, Sarr MG. ERCP-induced acute necrotizing pancreatitis: is it a more severe disease? Pancreas. 1997 Oct;15(3):217-21. doi: 10.1097/00006676-199710000-00001.

  PMID: 9336783 BACKGROUND

• Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.

  PMID: 2070995 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

plasma, mononuclear cell suspension

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Davor Štimac, MD, PhD

  Clinical Hospital Centre Rijeka

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doc.dr.sc. Goran Hauser, dr. med.

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: November 11, 2015
• Study Start: January 31, 2018
• Primary Completion: August 1, 2023
• Study Completion: January 1, 2024
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

CR (1)