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NCT Number: NCT04705740

Influence of the Endoscopists and Endoscopic Retrograde CholangioPanceratography

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

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Key information

Conditions

Biliary Disease Bile Duct Diseases Biliary Tract Diseases Choledocholithiasis Cholelithiasis Common Bile Duct Diseases Digestive System Diseases Gallbladder Diseases Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERCP

Other

ERCPs performed annually by an endoscopist

Primary outcomes

  1. Papillary cannulation

    Time frame: During the procedure

    Rate of papillary cannulation.Success in achieving transpapillary access to the bile duct.It has to be confirmed fluoroscopically

  2. Adverse effects

    Time frame: Up to 1 month after intervention

    Rate of adverse effect assessed by the ASGE classification

Secondary outcomes

  1. Individual adverse effects

    Time frame: Up to 1 month after intervention

    Rate of individual adverse effect during the intervention

  2. Complexity level of ERCP

    Time frame: During the ERCP procedure

    Complexity level of ERCP according to ASGE classification of complexity of the endoscopic procedures

  3. Therapeutics performed with ERCP

    Time frame: During the ERCP procedure

    Techniques used during ERCP

Sponsors and collaborators

Lead sponsor

Fundacion Miguel Servet

Other

Collaborators

  • Complejo Hospitalario de Navarra

Registry information

Official study title

Influence of the Endoscopist Case Volumen on Endoscopic Retrograde CholangioPanceratography Outcomes

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 12, 2021
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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