Pancreatic Diseases Clinical Trial
Official title:
Influence of the Endoscopist Case Volumen on Endoscopic Retrograde CholangioPanceratography Outcomes
NCT number | NCT04705740 |
Other study ID # | NER20 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2020 |
Est. completion date | October 31, 2020 |
Verified date | January 2021 |
Source | Fundacion Miguel Servet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Retrospective analysis on a prospective database that analyzes the influence of the number of endoscopists on the Endoscopic Retrograde CholangioPanceratography result.
Status | Completed |
Enrollment | 2561 |
Est. completion date | October 31, 2020 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Complejo Hospitalario de Navarra | Pamplona | Navarra |
Lead Sponsor | Collaborator |
---|---|
Fundacion Miguel Servet | Complejo Hospitalario de Navarra |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Papillary cannulation | Rate of papillary cannulation.Success in achieving transpapillary access to the bile duct.It has to be confirmed fluoroscopically | During the procedure | |
Primary | Adverse effects | Rate of adverse effect assessed by the ASGE classification | Up to 1 month after intervention | |
Secondary | Individual adverse effects | Rate of individual adverse effect during the intervention | Up to 1 month after intervention | |
Secondary | Complexity level of ERCP | Complexity level of ERCP according to ASGE classification of complexity of the endoscopic procedures | During the ERCP procedure | |
Secondary | Therapeutics performed with ERCP | Techniques used during ERCP | During the ERCP procedure |
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