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

• Register: ClinicalTrials.gov
• Last refreshed on: 30 May 2022
• Main ID: NCT02602574
• Date of registration: 29/10/2015
• Prospective Registration: Yes
• Primary sponsor: University Hospital Rijeka
• Public title: ERCP-induced and Non-ERCP Induced Acute Pancreatitis: Two Distinct Clinical and Immunological Entities?
• Scientific title: Endoscopic Retrograde Cholangiopancreatography (ERCP)-Induced and Non-ERCP Induced Acute Pancreatitis: Two Distinct Clinical and Immunological Entities?
• Date of first enrolment: January 31, 2018
• Target sample size: 66
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/show/NCT02602574
• Study type: Observational

Countries of recruitment

Croatia

Contacts

• Name: Davor Štimac, MD, PhD
• Affiliation: Clinical Hospital Centre Rijeka

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Post-ERCP Acute Pancreatitis

Intervention(s)

Other: heparinized peripheral venous blood and urine sample.

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Secondary ID(s)

PEP 2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors