Pancreatitis, AcutePEP-PROMISNCT07244432
Post-ERCP Pancreatitis - Prophylactic Measures Implementation Study (PEP-PROMIS)
An observational study of Pancreatitis, Acute and ERCP, run by Branislav Kuncak at 13 sites in 2 countries.
Trial summary
This is a prospective, observational (non-interventional), multicenter study that will look at how often inflammation of the pancreas (called post-ERCP pancreatitis, or PEP) occurs after an endoscopic procedure known as ERCP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis, Acute, ERCP, Prophylaxis
- How many people
- 1,135 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 1 Dec 2025to 31 May 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive adults undergoing ERCP at participating centers. Selected ERCP centers within the Slovakia and Czechia. The centers selected for this study are those that expressed interest in participating based on our yet unpublished 2024 survey, which aimed to assess how ERCP quality parameters were monitored and how prophylactic measures for PEP were implemented across centers. A total of 26 ERCP centers participated in the survey, including 14 from Slovakia and 12 from Czechia. Centers that expressed interest, as well as all remaining ERCP-performing centers in Slovakia and several in Czechia, were subsequently contacted by email with information about the study and invited to participate.
Who may be able to join
- ERCP in a patient with a native papilla (first ERCP) or repeat ERCP in a patient with previous failed cannulation attempt.
- Age at least 18 years at the time of ERCP.
- Signed informed consent.
Who cannot join
- Previous papillotomy, papilla dilation, or sphincteroplasty.
- Rendez-vous cannulation technique.
- ERCP not performed due to insufficient patient cooperation.
- ERCP terminated before cannulation due to sedation/anesthesia-related complications.
- Failure to reach the Vater's or minor papilla (e.g. duodenal stenosis).
- Acute biliary pancreatitis.
- Altered anatomy that prevents reaching the papilla with a standard duodenoscope (e.g. Roux-en-Y).
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Slovakia12 sites
F.D. Roosevelt University Hsopital
Banská Bystrica
University Hospital - St. Michael's Hospital, Bratislava
Bratislava, 81108
Bory Hospital
Bratislava
National Oncology Institute
Bratislava
University Hospital
Bratislava
University Hospital Martin
Martin
Klinika Orbis
Nitra
Hospital Poprad
Poprad
Faculty Hospital J.A.Reiman Prešov
Prešov
Faculty Hospital Trenčín
Trenčín
Faculty Hospital Trnava
Trnava
Faculty Hospital Žilina
Žilina
About this study
Official title: Post-ERCP Pancreatitis- Prophylactic Measures Implementation Study
This is a prospective, observational (non-interventional), multicenter study that will look at how often inflammation of the pancreas (called post-ERCP pancreatitis, or PEP) occurs after an endoscopic procedure known as ERCP. The study will take place in several hospitals in Slovakia and Czechia and will include all patients who have this procedure during the study period.
ERCP is a common procedure used to treat problems in the bile ducts and pancreas. Although generally safe, it sometimes leads to PEP, which is the most frequent and potentially serious complication. Monitoring the rate of PEP helps doctors evaluate the overall quality of ERCP procedures, since patient safety is an important part of quality care.
The study will also look at how well hospitals follow current prevention guidelines from two major professional organizations-the European Society of Gastrointestinal Endoscopy (ESGE) and the American Society for Gastrointestinal Endoscopy (ASGE)-and how these prevention methods affect the risk of PEP. This information will help identify how closely real-world practice follows recommended preventive measures and provide new data about PEP rates in the region.
- Conditions
- Pancreatitis, Acute, ERCP, Prophylaxis
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Consecutive adult patients with native papilla undergoing ERCP at participating centers. | Consecutive adult patients undergoing first endoscopic retrograde cholangiopancreatography (ERCP) or repeat ERCP after a previous failed cannulation attempt who have provided signed informed consent will be included. Patients will be excluded if they have a history of papillotomy, papilla dilation, or sphincteroplasty; if the rendezvous cannulation technique is used; if they show insufficient cooperation preventing cannulation; or if the ERCP is terminated before cannulation due to sedation- or anesthesia-related complications. Additional exclusion criteria include failure to reach the major or minor papilla (for example, due to duodenal stenosis), acute biliary pancreatitis, or altered anatomy preventing access to the papilla with a standard duodenoscope (such as Roux-en-Y reconstruction). The standard ERCP procedure will be performed under analgosedation or general anesthesia, depending on the patient's condition and the institutional protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who develop post-ERCP pancreatitis.
Measured: 48 hours after the procedure.
Secondary outcomes (4)
Percentage of participants experiencing none, mild, moderate, or severe post-ERCP pancreatitis.
Measured: Every 7 days until hospital discharge.
Proportion of ERCP procedures in which one or more guideline-recommended preventive measures are used.
Measured: Periprocedural preventive measures applied immediately before, during, or shortly after the ERCP procedure. Aggressive hydration may continue for up to 8 hours post-procedure.
Number of participants stratified by predefined patient- and procedure-related risk factors and occurrence of post-ERCP pancreatitis
Includes age, sex, ERCP indication, and ESGE-defined patient- and procedure-related risk factors
Measured: Periprocedurally
Number of participants with PEP-related mortality during index hospitalization or within 30 days after ERCP.
Measured: Up to 30 days post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Dec 2025
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, AcuteStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Branislav Kuncak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Branislav Kuncak, University Hospital Bratislava
- Investigators
- Jan Martinek, Prof, MD, Ph.D, Study chair, Gastroenterology, St. Anne´s University Hospital, Brno, Czech RepublicBranislav Kunčak, MUDr., Principal investigator, St. Michael´s University Hospital and Slovak Health University, Bratislava, Slovakia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244432
- Sponsor's protocol ID
- NSM-BA-PEP-PROMIS
- Acronym
- PEP-PROMIS
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-ERCP Pancreatitis- Prophylactic Measures Implementation Study
- ClinicalTrials.gov ID
- NCT07244432
- Acronym / sponsor ID
- PEP-PROMIS / NSM-BA-PEP-PROMIS
- Conditions
- Pancreatitis, Acute, ERCP, Prophylaxis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,135 participants (actual)
- Lead sponsor
- Branislav KuncakUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 24 Nov 2025 (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.
This is a prospective, observational (non-interventional), multicenter study that will look at how often inflammation of the pancreas (called post-ERCP pancreatitis, or PEP) occurs after an endoscopic procedure known as ERCP. The study will take place in several hospitals in Slovakia and Czechia and will include all patients who have this procedure during the study period.
ERCP is a common procedure used to treat problems in the bile ducts and pancreas. Although generally safe, it sometimes leads to PEP, which is the most frequent and potentially serious complication. Monitoring the rate of PEP helps doctors evaluate the overall quality of ERCP procedures, since patient safety is an important part of quality care.
The study will also look at how well hospitals follow current prevention guidelines from two major professional organizations-the European Society of Gastrointestinal Endoscopy (ESGE) and the American Society for Gastrointestinal Endoscopy (ASGE)-and how these prevention methods affect the risk of PEP. This information will help identify how closely real-world practice follows recommended preventive measures and provide new data about PEP rates in the region.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consecutive adult patients with native papilla undergoing ERCP at participating centers. | – | –Consecutive adult patients undergoing first endoscopic retrograde cholangiopancreatography (ERCP) or repeat ERCP after a previous failed cannulation attempt who have provided signed informed consent will be included. Patients will be excluded if they have a history of papillotomy, papilla dilation, or sphincteroplasty; if the rendezvous cannulation technique is used; if they show insufficient cooperation preventing cannulation; or if the ERCP is terminated before cannulation due to sedation- or anesthesia-related complications. Additional exclusion criteria include failure to reach the major or minor papilla (for example, due to duodenal stenosis), acute biliary pancreatitis, or altered anatomy preventing access to the papilla with a standard duodenoscope (such as Roux-en-Y reconstruction). The standard ERCP procedure will be performed under analgosedation or general anesthesia, depending on the patient's condition and the institutional protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive adults undergoing ERCP at participating centers. Selected ERCP centers within the Slovakia and Czechia. The centers selected for this study are those that expressed interest in participating based on our yet unpublished 2024 survey, which aimed to assess how ERCP quality parameters were monitored and how prophylactic measures for PEP were implemented across centers. A total of 26 ERCP centers participated in the survey, including 14 from Slovakia and 12 from Czechia. Centers that expressed interest, as well as all remaining ERCP-performing centers in Slovakia and several in Czechia, were subsequently contacted by email with information about the study and invited to participate.
Key inclusion criteria (3 listed)
- ERCP in a patient with a native papilla (first ERCP) or repeat ERCP in a patient with previous failed cannulation attempt.
- Age at least 18 years at the time of ERCP.
- Signed informed consent.
Key exclusion criteria (7 listed)
- Previous papillotomy, papilla dilation, or sphincteroplasty.
- Rendez-vous cannulation technique.
- ERCP not performed due to insufficient patient cooperation.
- ERCP terminated before cannulation due to sedation/anesthesia-related complications.
- Failure to reach the Vater's or minor papilla (e.g. duodenal stenosis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of participants who develop post-ERCP pancreatitis.
Time frame: 48 hours after the procedure.
4 secondary outcomes
Percentage of participants experiencing none, mild, moderate, or severe post-ERCP pancreatitis.
Time frame: Every 7 days until hospital discharge.
Proportion of ERCP procedures in which one or more guideline-recommended preventive measures are used.
Time frame: Periprocedural preventive measures applied immediately before, during, or shortly after the ERCP procedure. Aggressive hydration may continue for up to 8 hours post-procedure.
Number of participants stratified by predefined patient- and procedure-related risk factors and occurrence of post-ERCP pancreatitis
Time frame: Periprocedurally
Number of participants with PEP-related mortality during index hospitalization or within 30 days after ERCP.
Time frame: Up to 30 days post-procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
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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.
Jan Martinek, Prof, MD, Ph.D study chair
Gastroenterology, St. Anne´s University Hospital, Brno, Czech Republic
Branislav Kunčak, MUDr. principal investigator
St. Michael´s University Hospital and Slovak Health University, Bratislava, Slovakia
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis, Acute and ERCP, run by Branislav Kuncak at 13 sites in 2 countries.
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 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: finished, as of the sponsor's last update on 25 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 13 sites in Slovakia, Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of participants who develop post-ERCP pancreatitis. (time frame: 48 hours after the procedure.). 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 25 Aug 2026.