An observational study in Biliary Disease and Pancreatic Diseases, sponsored by Fundacion Miguel Servet. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-12.
Sponsored by Fundacion Miguel Servet · Observational
Retrospective analysis on a prospective database that analyzes the influence of the number of endoscopists on the Endoscopic Retrograde CholangioPanceratography result.
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.
92 studies on the registry are indexed under Gallbladder Diseases; 19 are open to participants now.
This study's enrollment of 2,561 is above the median of 220 across 29 observational studies indexed under Gallbladder Diseases.
Browse Gallbladder Diseases studies →Fundacion Miguel Servet is the lead sponsor of 48 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients over 18 years of age, undergoing ERCP by the staff allocated in the endoscopy unit.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
5 endoscopists
Other: ERCP
4 endoscopists
Other: ERCP
3 endoscopists
Other: ERCP
ERCPs performed annually by an endoscopist
Papillary cannulation
Rate of papillary cannulation.Success in achieving transpapillary access to the bile duct.It has to be confirmed fluoroscopically
Time frame: During the procedure
Adverse effects
Rate of adverse effect assessed by the ASGE classification
Time frame: Up to 1 month after intervention
Individual adverse effects
Rate of individual adverse effect during the intervention
Time frame: Up to 1 month after intervention
Complexity level of ERCP
Complexity level of ERCP according to ASGE classification of complexity of the endoscopic procedures
Time frame: During the ERCP procedure
Therapeutics performed with ERCP
Techniques used during ERCP
Time frame: During the ERCP procedure
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Fundacion Miguel Servet