Trial record 21 of 399 for:    pancreatitis

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Goran Hauser, University Hospital Rijeka
ClinicalTrials.gov Identifier:
NCT02602574
First received: October 29, 2015
Last updated: November 12, 2015
Last verified: November 2015
  Purpose

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 Intervention
Post-ERCP Acute Pancreatitis
Other: heparinized peripheral venous blood and urine sample.

Study Type: Observational
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by University Hospital Rijeka:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Number of Participants With Abnormal Laboratory Values


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Number of Participants With Abnormal Laboratory Values


Biospecimen Retention:   Samples With DNA
plasma, mononuclear cell suspension

Estimated Enrollment: 66
Study Start Date: December 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02602574

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

Publications:

Responsible Party: Goran Hauser, doc.dr.sc. Goran Hauser, dr. med., University Hospital Rijeka
ClinicalTrials.gov Identifier: NCT02602574     History of Changes
Other Study ID Numbers: PEP 2015 
Study First Received: October 29, 2015
Last Updated: November 12, 2015
Health Authority: Croatia: Ministry of Science, Education and Sports

Keywords provided by 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:
Pancreatitis
Digestive System Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on May 25, 2016