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2024-11-01
2025-10-30
2028-10-30
3000
NCT06670547
Germans Trias i Pujol Hospital
Germans Trias i Pujol Hospital
OBSERVATIONAL
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.
Currently, endoscopic retrograde cholangiopancreatography (ERCP) is a well-established procedure that is in continuous development, with an incidence and severity of adverse events (AEs) that differ substantially from those related to other endoscopic procedures, reaching up to 14.7% and with a mortality rate of 0.7%, even in expert centers 1. For this reason, it is essential to ensure the quality of ERCP procedures, requiring optimal training, capacity building and auditing to increase the success of the procedure and minimize the risk of complications 2. In recent years, the evaluation of the quality of ERCP has gained interest among health professionals and patient organizations. In 2018, the European Society of Gastrointestinal Endoscopy (ESGE) and the United European Gastroenterology (UEG) published key quality recommendations for ERCP and endoscopic ultrasonography with the aim of encouraging healthcare professionals to implement these performance targets at national level 3. For ERCP there are 5 recommendations including adequate antibiotic prophylaxis before ERCP (at least 90%), biliary cannulation rate (at least 90%), adequate stent placement in patients with sub-hilum obstruction (at least 95%), removal of bile duct stones (at least 90%) and post-ERCP pancreatitis (less than 10%). Following this line, endoscopists in the Netherlands have been using a mandatory nationwide quality register since 2016 (Trans.IT database; Rotterdam, the Netherlands), which provides information on the quality of ERCP 4. They have recently published the analysis of this register in relation to the ESGE quality recommendations. 5671 procedures performed by 57 endoscopists in 11 centres were included. Three key quality indicators were met: successful biliary cannulation, adequate placement of stents for biliary obstruction and removal of bile duct stones with a high overall success rate. These robust data from routine clinical practice also allow us to identify areas for improving the quality of ERCP, for example, successful cannulation of native papillae below 90% for endoscopists performing fewer than 50 procedures per year or the rate of adequate placement of biliary stents below 90% in endoscopists performing fewer than 25 procedures per year 5. Unfortunately, the rate of pancreatitis, which is the most appropriate indicator of the rate of adverse events, was not evaluated in this registry. In our view, the collection of data at a national level is of undoubted value to identify areas for improvement and to guarantee quality in ERCP, however, there are no state databases in our setting. The present study aims to evaluate the quality indicators of ERCP recommended by the ESGE-UEG in a Spanish prospective registry and to describe the real incidence of adverse events in clinical practice, and their association with technical aspects of the procedure.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-10-22 | N/A | 2024-10-31 |
2024-10-31 | N/A | 2024-11-01 |
2024-11-01 | N/A | 2024-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Patients with biliopancreatic pathology undergoing ERCP Patients with biliopancreatic pathology who undergo ERCP are over 18 years of age and sign the informed consent. | PROCEDURE: Endoscopic retrograde cholangiopancreatography (ERCP)
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry | Number of participants receiving adequate antibiotic prophylaxis before ERCP. | Patients receiving antibiotic prophylaxis of at least one dose of any systemic antibiotic in a 12-hour interval prior to ERCP. |
| To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry. | Number of participants who achieved biliary cannulation. | Patients in whom biliary cannulation is achieved up to 1 hour after completion of ERCP. |
| 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. | Patients who successfully placed stents in obstructions distal to the hilum up to 1 hour after completion of ERCP. |
| To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry. | Number of participants with successful removal of biliary tract stones. | Patients who successfully removed bile duct stones up to 1 hour after completion of ERCP. |
| To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry. | Number of participants developing post-ERCP pancreatitis. | Patients who developed acute pancreatitis at 7 and 30 days after ERCP. |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | Assessment of the development of adverse events at 24 hours according to the practice of each hospital; at 7 days and at 30 days after performing the ERCP by telephone call. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Edgar Castillo-Regalado, MD Phone Number: +34692338064 Email: eecastillor.germanstrias@gencat.cat |
Study Contact Backup Name: Juan Colán-Hernández, MD-PhD Phone Number: +34-629022059 Email: jacolanh.germanstrias@gencat.cat |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
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