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

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ClinicalTrials.gov Identifier: NCT02602574
Recruitment Status : Enrolling by invitation
First Posted : November 11, 2015
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Goran Hauser, University Hospital Rijeka

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.


Condition or disease Intervention/treatment
Post-ERCP Acute Pancreatitis Other: heparinized peripheral venous blood and urine sample.

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Study Type : Observational
Estimated Enrollment : 66 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Endoscopic Retrograde Cholangiopancreatography (ERCP)-Induced and Non-ERCP Induced Acute Pancreatitis: Two Distinct Clinical and Immunological Entities?
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
All patients will be taken 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.
All patients will be taken 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.
All patients will be taken heparinized peripheral venous blood and urine sample




Primary Outcome Measures :
  1. Evaluation of initial immunologic response in patients with PEP and patients with AP of other etiology (Number of Participants With Abnormal Laboratory Values) [ Time Frame: 24 hours after the primary injury ]
    Number of Participants With Abnormal Laboratory Values


Secondary Outcome Measures :
  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) [ Time Frame: 1 month ]
    Number of Participants With Abnormal Laboratory Values


Biospecimen Retention:   Samples With DNA
plasma, mononuclear cell suspension


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients with indication for ERCP and all patients with acute pancreatitis admitted through Emergency Department
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602574


Locations
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Croatia
Clinical Hospital Centre
Rijeka, Kresimirova 42, Croatia, 51000
Sponsors and Collaborators
University Hospital Rijeka
Investigators
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Study Chair: Davor Štimac, MD, PhD Clinical Hospital Centre Rijeka
Publications:

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Responsible Party: Goran Hauser, doc.dr.sc. Goran Hauser, dr. med., University Hospital Rijeka
ClinicalTrials.gov Identifier: NCT02602574    
Other Study ID Numbers: PEP 2015
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Keywords provided by Goran Hauser, University Hospital Rijeka:
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
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases