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Influence of the Endoscopists and Endoscopic Retrograde CholangioPanceratography

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ClinicalTrials.gov Identifier: NCT04705740
Recruitment Status : Completed
First Posted : January 12, 2021
Last Update Posted : January 12, 2021
Sponsor:
Collaborator:
Complejo Hospitalario de Navarra
Information provided by (Responsible Party):
Fundacion Miguel Servet

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

Condition or disease Intervention/treatment
Biliary Disease Pancreatic Diseases Other: ERCP

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.

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Study Type : Observational
Actual Enrollment : 2561 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Influence of the Endoscopist Case Volumen on Endoscopic Retrograde CholangioPanceratography Outcomes
Actual Study Start Date : September 1, 2020
Actual Primary Completion Date : September 30, 2020
Actual Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Group/Cohort Intervention/treatment
September 2013 to August 2015
5 endoscopists
Other: ERCP
ERCPs performed annually by an endoscopist

September 2015 to December 2017
4 endoscopists
Other: ERCP
ERCPs performed annually by an endoscopist

January 2018 to June 2020
3 endoscopists
Other: ERCP
ERCPs performed annually by an endoscopist




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients over 18 years of age, undergoing ERCP by the staff allocated in the endoscopy unit.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04705740


Locations
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Spain
Complejo Hospitalario de Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Fundacion Miguel Servet
Complejo Hospitalario de Navarra
Investigators
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Principal Investigator: Juan J Vila, PhD Complejo Hospitalario de Navarra
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Responsible Party: Fundacion Miguel Servet
ClinicalTrials.gov Identifier: NCT04705740    
Other Study ID Numbers: NER20
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundacion Miguel Servet:
ERCP
endoscopy
gastrointestinal
choledocholithiasis
Endoscopic Retrograde CholangioPanceratography
Additional relevant MeSH terms:
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Pancreatic Diseases
Gallbladder Diseases
Digestive System Diseases
Biliary Tract Diseases