Spanish Registry of Quality Indicators and Adverse Events of Endoscopic Retrograde Cholangiopancreatography

Endoscopic retrograde cholangiopancreatography (ERCP) is a technique which combines endoscopic and radiological vision and allows for therapeutic procedures on pathologies of the pancreas and bile duct. ERCP is a generally well tolerated procedure, nonetheless it is a complex technique that has a higher frequency of complications compared to most endoscopic procedures that can even be life-threatening. These complications are related to patient characteristics, experience of the endoscopist performing the procedure, and specific factors to the technique. Due to its complexity, quality assurance, operator training and auditing are required to increase success and minimize complications. There are quality indicators suggested by the main scientific societies in relation to technical aspects and complications, recommending their monitoring and auditing. Most endoscopy units lack records to monitor quality and complications, which prevents the assessment of quality and the identification of areas for improvement. Given the lack of evidence of the quality of ERCP in the Spanish population, the investigators will be conducting a multicenter, national prospective study that will include subjects who undergo ERCP. Patient data and technical aspects of the procedure will be recorded and all included patients will be monitored to identify complications. The quality indicators obtained within the registry will be compared with those established by scientific societies and the relationship between complications and technical factors will be analyzed.

NCT Number	NCT06670547
Lead Sponsor	Germans Trias i Pujol Hospital Collaborators: Spanish Society of Digestive Endoscopy
Conditions	Choledocholithiasis, Choledocholithiasis With Acute Cholangitis, Cholangiocarcinoma, Sclerosing Cholangitis, Pancreatic Cancer Resectable, Pancreatic Cancer Non-resectable, Biliary Fistula
Enrollment	3,000 participants
Start Date	2024-11-01
Primary Completion	2025-10-30 (estimated)
Study Completion	2028-10-30 (estimated)
Updated on ClinicalTrials.gov	2024-11-01