Clinical trial NCT04705740: Influence of the Endoscopists and Endoscopic Retrograde CholangioPanceratography
Official title: Influence of the Endoscopist Case Volumen on Endoscopic Retrograde CholangioPanceratography Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Disease
Pancreatic Diseases
Keywords: ERCP
endoscopy
gastrointestinal
choledocholithiasis
Endoscopic Retrograde CholangioPanceratography
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
Collaborators: name: Complejo Hospitalario de Navarra
First posted: 2021-01-12
Enrollment: 2561
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years of age, undergoing ERCP by the staff allocated in the endoscopy unit.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Papillary cannulation
timeFrame: During the procedure
measure: Adverse effects
timeFrame: Up to 1 month after intervention
Secondary outcomes:
measure: Individual adverse effects
timeFrame: Up to 1 month after intervention
measure: Complexity level of ERCP
timeFrame: During the ERCP procedure
measure: Therapeutics performed with ERCP
timeFrame: During the ERCP procedure
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
Study officials:
affiliation: Complejo Hospitalario de Navarra
name: Juan J Vila, PhD
role: PRINCIPAL_INVESTIGATOR
References: