Clinical trial NCT04341909: Trainee Involvement in ERCP Risk Score
Official title: Trainee Involvement in ERCP Risk Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bile Duct Diseases
Pancreas Cancer
Lead sponsor: Clinical Hospital Colentina
Sponsor class: OTHER
Collaborators: name: Policlinico Gemelli, Rome, Italy
name: Cantacuzino Clinical Hospital, Bucharest, Romania
name: Zadar Hospital, Zadar, Croatia
name: University of Belgrade
name: UHC Zagreb, Zagreb, Croatia
name: Oxford University Hospitals NHS Trust
name: University of Colorado, Denver, USA
name: Medical University, Sofia, Bulgaria
name: Universitaire Ziekenhuizen KU Leuven
name: ISUL Hospital, Sofia, Bulgaria
First posted: 2020-04-10
Enrollment: 1283
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all adult patients undergoing ERCP for any indication (diagnostic / therapeutic) in the participating centers

Brief summary: The study aims to evaluate factors associated with an increased risk of procedure related adverse events (including tecnical failure) of endoscopic retrograde cholangiopancreatography procedures (ERCP) conducted in a teaching setting, with trainee involvement.

Detailed description: The study aims to evaluate factors associated with an increased risk of procedure related adverse events (including tecnical failure) of endoscopic retrograde cholangiopancreatography procedures (ERCP) conducted in a teaching setting, with trainee involvement.

It has previously shown that ERCP procedures with trainee involvement have no additional risk for the patient, but we aim to evaluate whether a subgroup of high-risk procedures can be identified to allow an improvement of the teaching of ERCP, including identifying some high risk features that might indicate that trainee involvement should not be warranted.

Briefly, the study is observational in nature and aims to gather clinical data about the patient and technical data about the procedure (including the degree of trainee involvement( to assess which (if any) procedures carry a higher risk for the patient in a training setting.

data will be gathered using a standard report form completed by the attending endoscopist at the end of each procedure; the form will then be updated at 30days interval with data about potential adverse events.

Patient identity will be protected throughout the study as per regulations in each institution and country; also all patients will sign an informed consent prior to the endoscopic procedure and study enrollment.

Eligibility criteria: Inclusion Criteria:

* patients undergoing ERCP in the participating centers
* informed consent signed prior to the procedure

Exclusion Criteria:

* refusal to participate / sign the informed consent

Primary outcomes:
measure: any procedure related adverse outcome
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Colentina Clinical Hospital
Study officials:
affiliation: Colentina Clinical Hospital, UMF Carol Davila Faculty of Medicine
name: theodor voiosu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Voiosu T, Boskoski I, Voiosu AM, Bengus A, Ladic A, Klarin I, Bove V, Busuioc B, Rimbas M, Rustemovic N, Mateescu B, Jovanovic I, Costamagna G. Impact of trainee involvement on the outcome of ERCP procedures: results of a prospective multicenter observational trial. Endoscopy. 2020 Feb;52(2):115-122. doi: 10.1055/a-1049-0359. Epub 2019 Nov 25.