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

NCT ID: NCT07244432

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-05-31

Brief 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. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Branislav Kuncak

OTHER

Sponsor Role: lead

Responsible Party

Branislav Kuncak

Head of Gastroenterology, Principal Investigator, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jan Martinek, Prof, MD, Ph.D

Role: STUDY_CHAIR

Gastroenterology, St. Anne´s University Hospital, Brno, Czech Republic

Branislav Kunčak, MUDr.

Role: PRINCIPAL_INVESTIGATOR

St. Michael´s University Hospital and Slovak Health University, Bratislava, Slovakia

Central Contacts

Branislav Kuncak, MD

Role: CONTACT

branislav.kuncak@nsmas.sk

+421232611113

Rastislav Hustak, MD, Ph.D

Role: CONTACT

rastislav.hustak@fntt.sk

+421335938810

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NSM-BA-PEP-PROMIS

Identifier Type: -

Identifier Source: org_study_id