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Influence of the Endoscopists and Endoscopic Retrograde CholangioPanceratography

Influence of the Endoscopist Case Volumen on Endoscopic Retrograde CholangioPanceratography Outcomes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04705740
Enrollment
2561
Registered
2021-01-12
Start date
2020-09-01
Completion date
2020-10-31
Last updated
2021-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Disease, Pancreatic Diseases

Keywords

ERCP, endoscopy, gastrointestinal, choledocholithiasis, Endoscopic Retrograde CholangioPanceratography

Brief summary

Retrospective analysis on a prospective database that analyzes the influence of the number of endoscopists on the Endoscopic Retrograde CholangioPanceratography result.

Detailed description

The number of Endoscopic Retrograde CholangioPanceratographys (ERCP) performed annually by an endoscopist has been shown to influence the outcomes of the procedure, especially on the papillary cannulation rate and the adverse effects rate. The number of ERCPs performed annually by each endoscopist is directly related to the number of endoscopists who perform this procedure, since the total number of ERCPs performed annually at each center is usually constant. The hypothesis of this study is that the number of endoscopists who perform ERCP in a hospital influences the results of the procedure, so that the fewer the number of endoscopists the better the results. To evaluate this hypothesis, the investigators have designed a retrospective study analyzing data from a prospectively filled database, which includes all ERCPs performed in our center from September 2013 to June 2020. For organizative reasons unrelated to the endoscopy unit, in the center it has beed progressively reduced the number of endoscopists who perform ERCP, starting from 5 endoscopists at the beginning of the study to 3 endoscopists at the end of the study inclusion period. In fact, three different periods of similar duration can be distinguished: September 2013 to August 2015 (5 endoscopists), September 2015 to December 2017 (4 endoscopists) and January 2018 to June 2020 (3 endoscopists). The outcomes obtained with ERCP in these three periods will be analyzed and compared, assessing the cannulation rate and the adverse effects rate as the main comparison parameters.

Interventions

OTHERERCP

ERCPs performed annually by an endoscopist

Sponsors

Complejo Hospitalario de Navarra
CollaboratorOTHER
Fundacion Miguel Servet
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients undergoing ERCP with written informed consent given * Staff allocated in the endoscopy unit

Exclusion criteria

* Rejection to participate in the study * ERCP procedures performed by fellows in training

Design outcomes

Primary

MeasureTime frameDescription
Papillary cannulationDuring the procedureRate of papillary cannulation.Success in achieving transpapillary access to the bile duct.It has to be confirmed fluoroscopically
Adverse effectsUp to 1 month after interventionRate of adverse effect assessed by the ASGE classification

Secondary

MeasureTime frameDescription
Individual adverse effectsUp to 1 month after interventionRate of individual adverse effect during the intervention
Complexity level of ERCPDuring the ERCP procedureComplexity level of ERCP according to ASGE classification of complexity of the endoscopic procedures
Therapeutics performed with ERCPDuring the ERCP procedureTechniques used during ERCP

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026