Clinical trial · Observational
Trainee Involvement in ERCP Risk Score
NCT04341909CI-TRIAL-00058930TIERScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Diseases | — | UNRESOLVED | — |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERCP | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Trainee Group
- description
- Patients who undergo ERCPs with trainee involvement
- interventionNames
- Procedure: ERCP
- label
- control group
- description
- Patients who undergo ERCPs without any trainee involvement
- interventionNames
- Procedure: ERCP
Primary outcomes (1)
- measure
- any procedure related adverse outcome
- timeFrame
- 30 days
- description
- including but not limited to cholangitis, perforation, bleeding, technical failure, pancreatitis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDVoiosu 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. PMID 31766060