Influence of the Endoscopists and Endoscopic Retrograde CholangioPanceratography
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Papillary cannulation [During the procedure]
Rate of papillary cannulation.Success in achieving transpapillary access to the bile duct.It has to be confirmed fluoroscopically
- Adverse effects [Up to 1 month after intervention]
Rate of adverse effect assessed by the ASGE classification
Secondary Outcome Measures
- Individual adverse effects [Up to 1 month after intervention]
Rate of individual adverse effect during the intervention
- Complexity level of ERCP [During the ERCP procedure]
Complexity level of ERCP according to ASGE classification of complexity of the endoscopic procedures
- Therapeutics performed with ERCP [During the ERCP procedure]
Techniques used during ERCP
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Complejo Hospitalario de Navarra | Pamplona | Navarra | Spain | 31008 |
Sponsors and Collaborators
- Fundacion Miguel Servet
- Complejo Hospitalario de Navarra
Investigators
- Principal Investigator: Juan J Vila, PhD, Complejo Hospitalario de Navarra
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NER20