Endoscopy Clinical Trials

Clinical trials related to Endoscopy Procedure

Post-ERCP Pancreatitis- Prophylactic Measures Implementation Study

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Slovakia
University Hospital - St. Michael's Hospital, Bratislava
RECRUITING
Bratislava
Contact Information
Primary
Branislav Kuncak, MD
branislav.kuncak@nsmas.sk
+421232611113
Backup
Rastislav Hustak, MD, Ph.D
rastislav.hustak@fntt.sk
+421335938810
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 1000
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Branislav Kuncak

This content was sourced from clinicaltrials.gov