MedTrace Logo

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

NCT06670547 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2024-11-01

No results posted yet for this study

Summary

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.

Conditions

  • Choledocholithiasis
  • Choledocholithiasis With Acute Cholangitis
  • Cholangiocarcinoma
  • Sclerosing Cholangitis
  • Pancreatic Cancer Resectable
  • Pancreatic Cancer Non-resectable
  • Biliary Fistula

Interventions

PROCEDURE

Endoscopic retrograde cholangiopancreatography (ERCP)

Endoscopic retrograde cholangiopancreatography (ERCP)

Sponsors & Collaborators

  • Spanish Society of Digestive Endoscopy

    collaborator OTHER

  • Germans Trias i Pujol Hospital

    lead OTHER

Principal Investigators

  • Edgar Castillo-Regalado, MD · Hospital Universitario Germans Trias i Pujol (Badalona)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-10-30
Completion
2028-10-30

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06670547 on ClinicalTrials.gov