Post-ERCP Acute PancreatitisG-PEPNCT05267379
An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis
An observational study of Post-ERCP Acute Pancreatitis, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) comes with a risk for post-ERCP pancreatitis (PEP), which accounts for considerable morbidity, high healthcare expenditure, and death. The pathophysiology of PEP and the underpinnings of the preventive effect of rectal NSAID (RN) is poorly understood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-ERCP Acute Pancreatitis
- What is being tested?
- Take blood samples
- How many people
- 700 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2022to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years or older with an indication to undergo an ERCP, without pancreatic cancer, chronic pancreatitis, altered anatomy of the upper digestive tract and an ongoing acute pancreatitis.
Who may be able to join
- Age ≥ 18 years
- written informed consent
- Indication to undergo an ERCP
Who cannot join
- Pancreatic cancer
- Chronic pancreatitis
- Ongoing acute pancreatitis
- Altered anatomy, defined as anatomical variations in which gall and/or pancreatic juices (in case of pancreatic duct interventions) do not enter the duodenum by way of the ampulla of Vater.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
RadboudUMC
Nijmegen, Gelderland, 6525 GA
Mike de Jong, MD, 0031883207054, mike.dejong@radboudumc.nl
Erwin van Geenen, MD, PhD, 0031243619190, erwin.vangeenen@radboudumc.nl
About this study
Endoscopic retrograde cholangiopancreatography (ERCP) comes with a risk for post-ERCP pancreatitis (PEP), which accounts for considerable morbidity, high healthcare expenditure, and death. The pathophysiology of PEP and the underpinnings of the preventive effect of rectal NSAID (RN) is poorly understood. Guidelines advise to take preventive measures with a single dose of 100mg RN, peri-ERCP. While NSAID administration reduces the risk with 40%, PEP still occurs after ERCP. In addition, patients with a PEP history have a higher risk to develop recurrence after a subsequent ERCP. This might suggest that an underlying genetic risk may contribute to increasing the incidence of PEP in some patients.
Read the detailed description
This study is a hypothesis driven and hypothesis free analyses of PEP risk variants. Integrative analysis of NSAID pharmacokinetics and-genetics in PEP patients.
- Conditions
- Post-ERCP Acute Pancreatitis
- Being tested
- Take blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Take blood samplesDiagnostic test
Blood samples are used to check for polymorphisms in NSAID metabolization genes and to determine the diclofenac levels.
| Study group | Role | What they receive |
|---|---|---|
| PEP patients | Patients who develop PEP Receives: Diagnostic Test: Take blood samples | |
| Control cohort | Patients who do not develop PEP Receives: Diagnostic Test: Take blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in SNP's in NSAID metabolization genes
Analyzing differences in polymorphisms in NSAID metabolization genes between PEP patients and control patients using Taqman assay. DNA will be isolated from blood samples and analyzed for SNP's of biotransformation enzymes such as UDP-Glucuronosyltransferase-2B7 (UGT2B7) and CYP2C9. This will be done using polymerase chain reaction (PCR) with fluorescent probes specific for a SNP (Taqman assay)
Measured: 1 month
Secondary outcomes (3)
Diclofenac levels
Detection of diclofenac levels two hours after diclofenac administration. Levels will be measured in blood samples by high-performance liquid chromatography (HPLC).
Measured: 2 hours
Correlation diclofenac levels and NSAID metabolization gene polymorphisms
To investigate whether there is a correlation between diclofenac levels and NSAID metabolism gene polymorphisms. Using an independent t-test, the investigators will try to find a significant correlation between the diclofenac levels and a difference in single nucleotide polymorphism (SNP).
Measured: 1 month
Genes involved in development of PEP
To investigate whether the known genes involved in developing acute pancreatitis also are involved in developing PEP. DNA isolated from the blood samples will be analyzed by Miniseq-technique.
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 posted4 Mar 2022
- Study start1 Mar 2022
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-ERCP Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erwin van Geenen, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267379
- Sponsor's protocol ID
- 108224
- Acronym
- G-PEP
- Status last verified
- Aug 2026
- First submitted
- 24 Jan 2022
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The dataset used during this study is available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis
- ClinicalTrials.gov ID
- NCT05267379
- Acronym / sponsor ID
- G-PEP / 108224
- Conditions
- Post-ERCP Acute Pancreatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 4 Mar 2022 (actual)
- 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.
Endoscopic retrograde cholangiopancreatography (ERCP) comes with a risk for post-ERCP pancreatitis (PEP), which accounts for considerable morbidity, high healthcare expenditure, and death. The pathophysiology of PEP and the underpinnings of the preventive effect of rectal NSAID (RN) is poorly understood. Guidelines advise to take preventive measures with a single dose of 100mg RN, peri-ERCP. While NSAID administration reduces the risk with 40%, PEP still occurs after ERCP. In addition, patients with a PEP history have a higher risk to develop recurrence after a subsequent ERCP. This might suggest that an underlying genetic risk may contribute to increasing the incidence of PEP in some patients.
Detailed description
This study is a hypothesis driven and hypothesis free analyses of PEP risk variants. Integrative analysis of NSAID pharmacokinetics and-genetics in PEP patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEP patients | – | Diagnostic Test: Take blood samplesPatients who develop PEP |
| Control cohort | – | Diagnostic Test: Take blood samplesPatients who do not develop PEP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or older with an indication to undergo an ERCP, without pancreatic cancer, chronic pancreatitis, altered anatomy of the upper digestive tract and an ongoing acute pancreatitis.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- written informed consent
- Indication to undergo an ERCP
Key exclusion criteria (4 listed)
- Pancreatic cancer
- Chronic pancreatitis
- Ongoing acute pancreatitis
- Altered anatomy, defined as anatomical variations in which gall and/or pancreatic juices (in case of pancreatic duct interventions) do not enter the duodenum by way of the ampulla of Vater.
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 |
|---|---|---|
| Take blood samplesBlood samples are used to check for polymorphisms in NSAID metabolization genes and to determine the diclofenac levels. | Diagnostic test | Control cohort, PEP patients |
Primary outcome
Differences in SNP's in NSAID metabolization genes
Time frame: 1 month
Analyzing differences in polymorphisms in NSAID metabolization genes between PEP patients and control patients using Taqman assay. DNA will be isolated from blood samples and analyzed for SNP's of biotransformation enzymes such as UDP-Glucuronosyltransferase-2B7 (UGT2B7) and CYP2C9. This will be done using polymerase chain reaction (PCR) with fluorescent probes specific for a SNP (Taqman assay)
3 secondary outcomes
Diclofenac levels
Time frame: 2 hours
Correlation diclofenac levels and NSAID metabolization gene polymorphisms
Time frame: 1 month
Genes involved in development of PEP
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Undecided. The dataset used during this study is available from the corresponding author upon reasonable request.
Related trials for Post-ERCP Acute Pancreatitis
Not yet recruiting
Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
Post ERCP Pancreatitis, Acute Pancreatitis (AP)
Not yet recruiting
Prophylactic Sphincterotomy in Acute Biliary Pancreatitis Patients Unfit for Surgery
Acute Biliary Pancreatitis
Recruiting
Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis
Pancreatitis, Acute
Not yet recruitingPhase 4
Indomethacin for Biliary ERCP Patients
Pancreatitis Biliary, Pancreatitis Acute Biliary
RecruitingPhase 4
Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis
Post-ERCP Acute Pancreatitis
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.
Erwin van Geenen, MD, PhD principal investigator
Radboud University Medical Center
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 Radboud University Medical Center at 1 site in Netherlands.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 21 Aug 2026. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mike de Jong, MD (0031883207054, mike.dejong@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in SNP's in NSAID metabolization genes (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2026.