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

October 31, 2024 updated by: Germans Trias i Pujol Hospital

Prospective and Multicenter 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with biliopancreatic pathology for whom ERCP is performed in hospitals in Spain.

Description

Inclusion Criteria:

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:

  • Over 18 years of age
  • Signed informed consent.

Exclusion Criteria:

  • Under 18 years of age
  • Unavailability of informed consent
  • Impossibility of follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)
Endoscopic retrograde cholangiopancreatography (ERCP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry
Time Frame: Patients receiving antibiotic prophylaxis of at least one dose of any systemic antibiotic in a 12-hour interval prior to ERCP.
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.
Time Frame: Patients in whom biliary cannulation is achieved up to 1 hour after completion of ERCP.
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.
Time Frame: Patients who successfully placed stents in obstructions distal to the hilum up to 1 hour after completion of ERCP.
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.
Time Frame: Patients who successfully removed bile duct stones up to 1 hour after completion of ERCP.
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.
Time Frame: Patients who developed acute pancreatitis at 7 and 30 days after ERCP.
Number of participants developing post-ERCP pancreatitis.
Patients who developed acute pancreatitis at 7 and 30 days after ERCP.

Secondary Outcome Measures

Outcome Measure
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
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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Germans Trias i Pujol Hospital

Collaborators

Spanish Society of Digestive Endoscopy

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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 Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

October 30, 2028

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 31, 2024

First Posted (Estimated)

November 1, 2024

Study Record Updates

Last Update Posted (Estimated)

November 1, 2024

Last Update Submitted That Met QC Criteria

October 31, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI-23-281

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Beginning 10 months and ending 2 years after the publication of results.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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