Post-ERCP Acute PancreatitisNCT02602574
ERCP-induced and Non-ERCP Induced Acute Pancreatitis: Two Distinct Clinical and Immunological Entities?
An observational study of Post-ERCP Acute Pancreatitis, run by University Hospital Rijeka at 1 site in Croatia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-ERCP Acute Pancreatitis
- What is being tested?
- heparinized peripheral venous blood and urine sample.
- How many people
- 66 participants
- Where
- 1 siteCroatia
- Study dates
- 31 Jan 2018to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with indication for ERCP and all patients with acute pancreatitis admitted through Emergency Department
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Retrograde Cholangiopancreatography (ERCP)-Induced and Non-ERCP Induced Acute Pancreatitis: Two Distinct Clinical and Immunological Entities?
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.
Read the detailed description
PROTOCOL:
All patients with indication for endoscopic retrograde cholangiopancreatography (ERCP) will be prepared for ERCP on the following protocol: they will be instructed not to eat 4 to 6 hours before the procedure. Immediately before the procedure they will be administrated with Diclophenac Sodium 100 mg suppositories. One hour before the procedure 10 mL of blood sample and urine sample will be taken and analyzed in laboratory premises incorporated in University Hospital Centre Rijeka for following parameters: values of amylase in serum and urine and lipase in serum, liver enzyme tests and kidney function. 4-6 hours after ERCP is performed, 10 mL of blood sample will be taken and analyzed in laboratory premises incorporated in University Hospital Centre Rijeka for following parameters: values of amylase in serum and urine and lipase in serum, liver enzyme tests and kidney function.
24 hours after the procedure all patients will be taken 30 ml of heparinized peripheral venous blood and urine sample. 10 mL will be examined in the Department of Laboratory Medicine, Clinical Hospital Centre for following parameters: values of amylase in serum and urine and lipase in serum, liver enzyme tests and kidney function. Urine sample collected after the procedure will be used to evaluate amylase levels. Other 20 mL of blood samples will be sent to Department of Physiology and Immunology, School of Medicine where immunologic analysis will be performed. All patients who underwent ERCP will be divided into two groups. First group (PEP group) will be made of patients who developed acute pancreatitis following ERCP. Upon clinical and laboratory confirmation of acute pancreatitis according to European Society of Gastrointestinal Endoscopy (ESGE) guidelines for post-ERCP pancreatitis, will be further monitored during hospitalization for evaluation of the severity of the disease. Severity of the disease will be assessed according to the Cotton criteria for the severity of post-ERCP pancreatitis. Group of patients who underwent ERCP but didn't develop acute pancreatitis within 24 hours after the procedure, according to ESGE guidelines will be used as a control group (non-PEP group).
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 (upper abdominal pain often radiating through to the back). 10 mL of collected blood samples will be examined in the Department of Laboratory Medicine, Clinical Hospital Centre for following parameters: values of amylase in serum and urine and lipase in serum, liver enzyme tests and kidney function. 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.
METHODS AND MATERIALS
Laboratory parameters
For each patient included in the study blood and urine analysis will be performed in the Department of Laboratory Medicine, Clinical Hospital Centre Rijeka. Basic hematology tests will include: total blood count - a count of the total number of red blood cells, white blood cells and platelets present in blood, values of hemoglobin and hematocrit. Biochemical analysis of blood serum will include: values of amylase and lipase in serum, sodium, potassium, glucose, liver enzymes (aspartate aminotransferase (AST), alanine aminotransferase (ALT), Gama-glutamyl transferase (GGT), alkaline phosphatase (ALP)) direct and indirect bilirubin, kidney function (serum urea and creatinine, estimated glomerular filtration (eGFR)), C-reactive protein and acid-base status of arterial blood.
Immunological methods
For each patient included in the study immunologic analysis of blood samples (24 hours after the procedure or onset of the symptoms) will be performed in Department of Physiology and Immunology, School of Medicine in Rijeka, Croatia.
Isolation of peripheral blood mononuclear cells Twenty milliliters of peripheral blood will be acquired in Vacutainer (Becton Dickinson, Franklin Lakes, NY), overlaid onto Lymphoprep (Nycomed Pharma AS, Oslo, Norway) and centrifuged (20 min at 600 g). After the centrifugation, the cells from the interface will be collected and washed twice in Roswell Park Memorial Institute (RPMI) 1640 medium (Auckland, NZ) and used immediately for further experimental procedure. The viability of the cells was >95% will be assessed with propidium iodide 0.5 mg/ml/106 cells (Sigma-Aldrich Chemie) and a flow cytometer (FACSCalibur, Becton Dickinson, San Jose, USA)
Detection of cell surface Peripheral blood mononuclear cells (PBMC) will be stained for 30 min at 40 degrees Celsius with different combinations of Phycoerythrin (PE) - Cyanine (Cy) anti-cluster of differentiation (CD) 3 monoclonal antibody (mouse Antibody (mAb), Immunoglobulin G 1 (IgG1)), PE-conjugated anti-cluster of differentiation (CD)56 mAb (mouse B159, IgG1) and fluorescein isothiocyanate (FITC)-conjugated anti-natural-killer group 2, member D (NKG2D) mAb (5C6). FITC-, PE- and PE-Cy conjugated mouse isotype match antibodies will be used to set negative controls for each class of antibody used.
Stained cell samples will be analyzed by flow cytometry using FACSCalibur flow cytometer (Becton Dickinson \& Co, San Jose, USA).
Detection of cytokine Interleukin (IL)-1 beta (β) and heat shock protein (HSP) 70, 27.
For the quantitative determination of human IL-1 β concentrations in plasma,Human IL-1 ELISA (Enzyme-Linked Immunosorbent Assay) Kit will be used.
For the quantitative determination of heat shock protein (HSP) 70 and 27 in plasma, HSP 70 High sensitivity ELISA Kit and HSP 27 ELISA kit will be used.
Detection of pentraxin 3 (PTX 3) and procalcitonin For the quantitative determination of human pentraxin 3 (PTX) and procalcitonin concentrations in plasma specific ELISA Kit will be used.
- Conditions
- Post-ERCP Acute Pancreatitis
- Being tested
- heparinized peripheral venous blood and urine sample.
- 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
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heparinized peripheral venous blood and urine sample.Other
All patients will be taken heparinized peripheral venous blood and urine sample
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: heparinized peripheral venous blood and urine sample. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Number of Participants With Abnormal Laboratory Values
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study start31 Jan 2018
- Primary completionAug 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Post-ERCP Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Rijeka
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goran Hauser, University Hospital Rijeka
- Investigators
- Davor Štimac, MD, PhD, Study chair, Clinical Hospital Centre Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602574
- Sponsor's protocol ID
- PEP 2015
- Status last verified
- May 2022
- First submitted
- 29 Oct 2015
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23100216Yadav 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.
PubMed 23622135Dumonceau 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.
PubMed 25148137Kylanpaa 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.
PubMed 23304633Demols A, Deviere J. New frontiers in the pharmacological prevention of post-ERCP pancreatitis: the cytokines. JOP. 2003 Jan;4(1):49-57.
PubMed 12555016Testoni 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.
PubMed 20018574Fung 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.
PubMed 9336783Cotton 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.
PubMed 2070995
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Retrograde Cholangiopancreatography (ERCP)-Induced and Non-ERCP Induced Acute Pancreatitis: Two Distinct Clinical and Immunological Entities?
- ClinicalTrials.gov ID
- NCT02602574
- Acronym / sponsor ID
- PEP 2015
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University Hospital RijekaUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PROTOCOL:
All patients with indication for endoscopic retrograde cholangiopancreatography (ERCP) will be prepared for ERCP on the following protocol: they will be instructed not to eat 4 to 6 hours before the procedure. Immediately before the procedure they will be administrated with Diclophenac Sodium 100 mg suppositories. One hour before the procedure 10 mL of blood sample and urine sample will be taken and analyzed in laboratory premises incorporated in University Hospital Centre Rijeka for following parameters: values of amylase in serum and urine and lipase in serum, liver enzyme tests and kidney function. 4-6 hours after ERCP is performed, 10 mL of blood sample will be taken and analyzed in laboratory premises incorporated in University Hospital Centre Rijeka for following parameters: values of amylase in serum and urine and lipase in serum, liver enzyme tests and kidney function.
24 hours after the procedure all patients will be taken 30 ml of heparinized peripheral venous blood and urine sample. 10 mL will be examined in the Department of Laboratory Medicine, Clinical Hospital Centre for following parameters: values of amylase in serum and urine and lipase in serum, liver enzyme tests and kidney function. Urine sample collected after the procedure will be used to evaluate amylase levels. Other 20 mL of blood samples will be sent to Department of Physiology and Immunology, School of Medicine where immunologic analysis will be performed. All patients who underwent ERCP will be divided into two groups. First group (PEP group) will be made of patients who developed acute pancreatitis following ERCP. Upon clinical and laboratory confirmation of acute pancreatitis according to European Society of Gastrointestinal Endoscopy (ESGE) guidelines for post-ERCP pancreatitis, will be further monitored during hospitalization for evaluation of the severity of the disease. Severity of the disease will be assessed according to the Cotton criteria for the severity of post-ERCP pancreatitis. Group of patients who underwent ERCP but didn't develop acute pancreatitis within 24 hours after the procedure, according to ESGE guidelines will be used as a control group (non-PEP group).
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 (upper abdominal pain often radiating through to the back). 10 mL of collected blood samples will be examined in the Department of Laboratory Medicine, Clinical Hospital Centre for following parameters: values of amylase in serum and urine and lipase in serum, liver enzyme tests and kidney function. 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.
METHODS AND MATERIALS
Laboratory parameters
For each patient included in the study blood and urine analysis will be performed in the Department of Laboratory Medicine, Clinical Hospital Centre Rijeka. Basic hematology tests will include: total blood count - a count of the total number of red blood cells, white blood cells and platelets present in blood, values of hemoglobin and hematocrit. Biochemical analysis of blood serum will include: values of amylase and lipase in serum, sodium, potassium, glucose, liver enzymes (aspartate aminotransferase (AST), alanine aminotransferase (ALT), Gama-glutamyl transferase (GGT), alkaline phosphatase (ALP)) direct and indirect bilirubin, kidney function (serum urea and creatinine, estimated glomerular filtration (eGFR)), C-reactive protein and acid-base status of arterial blood.
Immunological methods
For each patient included in the study immunologic analysis of blood samples (24 hours after the procedure or onset of the symptoms) will be performed in Department of Physiology and Immunology, School of Medicine in Rijeka, Croatia.
Isolation of peripheral blood mononuclear cells Twenty milliliters of peripheral blood will be acquired in Vacutainer (Becton Dickinson, Franklin Lakes, NY), overlaid onto Lymphoprep (Nycomed Pharma AS, Oslo, Norway) and centrifuged (20 min at 600 g). After the centrifugation, the cells from the interface will be collected and washed twice in Roswell Park Memorial Institute (RPMI) 1640 medium (Auckland, NZ) and used immediately for further experimental procedure. The viability of the cells was >95% will be assessed with propidium iodide 0.5 mg/ml/106 cells (Sigma-Aldrich Chemie) and a flow cytometer (FACSCalibur, Becton Dickinson, San Jose, USA)
Detection of cell surface Peripheral blood mononuclear cells (PBMC) will be stained for 30 min at 40 degrees Celsius with different combinations of Phycoerythrin (PE) - Cyanine (Cy) anti-cluster of differentiation (CD) 3 monoclonal antibody (mouse Antibody (mAb), Immunoglobulin G 1 (IgG1)), PE-conjugated anti-cluster of differentiation (CD)56 mAb (mouse B159, IgG1) and fluorescein isothiocyanate (FITC)-conjugated anti-natural-killer group 2, member D (NKG2D) mAb (5C6). FITC-, PE- and PE-Cy conjugated mouse isotype match antibodies will be used to set negative controls for each class of antibody used.
Stained cell samples will be analyzed by flow cytometry using FACSCalibur flow cytometer (Becton Dickinson \& Co, San Jose, USA).
Detection of cytokine Interleukin (IL)-1 beta (β) and heat shock protein (HSP) 70, 27.
For the quantitative determination of human IL-1 β concentrations in plasma,Human IL-1 ELISA (Enzyme-Linked Immunosorbent Assay) Kit will be used.
For the quantitative determination of heat shock protein (HSP) 70 and 27 in plasma, HSP 70 High sensitivity ELISA Kit and HSP 27 ELISA kit will be used.
Detection of pentraxin 3 (PTX 3) and procalcitonin For the quantitative determination of human pentraxin 3 (PTX) and procalcitonin concentrations in plasma specific ELISA Kit will be used.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ERCP- induced acute pancreatitis | – | Other: heparinized peripheral venous blood and urine sample.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. |
| non -ERCP acute pancreatitis | – | Other: heparinized peripheral venous blood and urine sample.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. |
| Control group | – | Other: heparinized peripheral venous blood and urine sample.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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with indication for ERCP and all patients with acute pancreatitis admitted through Emergency Department
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heparinized peripheral venous blood and urine sample.All patients will be taken heparinized peripheral venous blood and urine sample | Other | Control group, ERCP- induced acute pancreatitis, non -ERCP acute pancreatitis |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Background: PubMed 23100216Banks 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.
- Background: PubMed 23622135Yadav 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.
- Background: PubMed 25148137Dumonceau 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.
- Background: PubMed 23304633Kylanpaa 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.
- Background: PubMed 12555016Demols A, Deviere J. New frontiers in the pharmacological prevention of post-ERCP pancreatitis: the cytokines. JOP. 2003 Jan;4(1):49-57.
- Background: PubMed 20018574Testoni 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.
- Background: PubMed 9336783Fung 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.
- Background: PubMed 2070995Cotton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davor Štimac, MD, PhD study chair
Clinical Hospital Centre Rijeka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-ERCP Acute Pancreatitis, run by University Hospital Rijeka at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02602574, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.