An observational study in Choledocholithiasis, Choledocholithiasis With Acute Cholangitis and Cholangiocarcinoma, sponsored by Germans Trias i Pujol Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-01.
Sponsored by Germans Trias i Pujol Hospital · Observational
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.
109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 200 across 31 observational studies indexed under Choledocholithiasis.
Browse Choledocholithiasis studies →Germans Trias i Pujol Hospital is the lead sponsor of 89 studies on the registry; 12 are open to participants now.
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Patients with biliopancreatic pathology for whom ERCP is performed in hospitals in Spain.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All consecutive patients who have undergone an ERCP at participating centres from 1 November 2024 will be included. An ERCP will be considered to have been performed when an endoscope is introduced to access the duodenal papilla.
These included patients must meet all of the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with biliopancreatic pathology who undergo ERCP are over 18 years of age and sign the informed consent.
Procedure: Endoscopic retrograde cholangiopancreatography (ERCP)
Endoscopic 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Patients who developed acute pancreatitis at 7 and 30 days after ERCP.
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
Time frame: 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.
No study locations are listed for this record.
Plan to share: Yes — Data obtained through this study may be provided to qualified researchers with academic interest in ERCP and biliopancreatic diseases. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting 10 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Beginning 10 months and ending 2 years after the publication of results.
Access criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement.
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Germans Trias i Pujol Hospital