Post-ERCP Pancreatitis - Prophylactic Measures Implementation Study (PEP-PROMIS)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBranislav Kuncak

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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 The centers selected for this study are those that expressed interest in participating based on our yet unpublished 2024 survey, which aimed to assess how ERCP quality parameters were monitored and how prophylactic measures for PEP were implemented across centers.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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: Consecutive adult patients with native papilla undergoing ERCP at participating centers.

Trial outcomes

Primary outcomes

1

Percentage of participants who develop post-ERCP pancreatitis.

Time frame
48 hours after the procedure.

Secondary outcomes

1

Percentage of participants experiencing none, mild, moderate, or severe post-ERCP pancreatitis.

Time frame
Every 7 days until hospital discharge.
2

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.
3

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

Time frame
Periprocedurally
4

Number of participants with PEP-related mortality during index hospitalization or within 30 days after ERCP.

Time frame
Up to 30 days post-procedure.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Branislav Kuncak

Lead sponsor

University Hospital Bratislava

Sponsor institution