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.
Over 18 years of age
Signed informed consent.
Under 18 years of age
Unavailability of informed consent
Impossibility of follow-up.
Patients with biliopancreatic pathology for whom ERCP is performed in hospitals in Spain.
Cohort
Prospective
Endoscopic retrograde cholangiopancreatography (ERCP)
Procedure/SurgeryEndoscopic retrograde cholangiopancreatography (ERCP)
To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry
Number of participants receiving adequate antibiotic prophylaxis before ERCP.
To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry.
Number of participants who achieved biliary cannulation.
To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry.
Number of participants in whom stents are successfully placed in obstructions distal to the hilum.
To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry.
Number of participants with successful removal of biliary tract stones.
To describe the severity of adverse events in ERCP according to the AGREE classification and their association with technical aspects of the procedure
Number adverse event (AE)A telephone contact with general practitioner, outpatient clinic, or endoscopy service without any intervention or extended observation of the patient after the procedure (3 hours without any intervention) Grade I AE with any deviation of the standard post-procedural course, without pharmacologic treatment or endoscopic, radiologic, or surgical interventions, Hospital admission (24 hours), without any intervention, Allowed therapeutic regimens are antiemetics, antipyretics, analgesics and electrolytes or Allowed diagnostic radiology and laboratory tests Grade II AE requiring pharmacologic treatment with drugs other than those allowed for grade I AE or Blood product transfusions or Hospital admission for more than 24 hours Grade Illa AE requiring endoscopic or radiologic intervention Grade Illb Surgical intervention Grade IV AE requiring intensive care unit IVa Single-organ dysfunction including dialysis IVb Multiorgan dysfunction Grade V Death of patient
Click on the lead sponsor to view all of their trials.
Germans Trias i Pujol Hospital
Lead sponsor
Spanish Society of Digestive Endoscopy
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
