Trainee Involvement in ERCP Risk Score

Pancreas Cancer Clinical Trial

— TIERS  

Official title:

Trainee Involvement in ERCP Risk Score

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04341909
• Other study ID #: TIERS
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: June 2022
• Source: Clinical Hospital Colentina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1283
• Est. completion date: January 1, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Diseases
• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• ERCP
endoscopic retrograde cholangiopancreatography

Locations

Country	Name	City	State
Romania	Colentina Clinical Hospital	Bucharest

Sponsors (11)

Lead Sponsor	Collaborator
Clinical Hospital Colentina	Cantacuzino Clinical Hospital, Bucharest, Romania, ISUL Hospital, Sofia, Bulgaria, Medical University, Sofia, Bulgaria, Oxford University Hospital, Oxford, UK, Policlinico Gemelli, Rome, Italy, UHC Zagreb, Zagreb, Croatia, Universitaire Ziekenhuizen Leuven, University of Belgrade, University of Colorado, Denver, USA, Zadar Hospital, Zadar, Croatia

Country where clinical trial is conducted

Romania, 

References & Publications (1)

Voiosu T, Boskoski I, Voiosu AM, Bengu? A, Ladic A, Klarin I, Bove V, Busuioc B, Rimba? 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	any procedure related adverse outcome	including but not limited to cholangitis, perforation, bleeding, technical failure, pancreatitis	30 days