Trainee Involvement in ERCP Risk Score (TIERS)

June 4, 2022 updated by: dr. Theodor Alexandru Voiosu, Clinical Hospital Colentina
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1283

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania
        • Colentina Clinical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

all adult patients undergoing ERCP for any indication (diagnostic / therapeutic) in the participating centers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Trainee Group
Patients who undergo ERCPs with trainee involvement
Procedure: ERCP
endoscopic retrograde cholangiopancreatography
control group
Patients who undergo ERCPs without any trainee involvement
Procedure: ERCP
endoscopic retrograde cholangiopancreatography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
any procedure related adverse outcome
Time Frame: 30 days
including but not limited to cholangitis, perforation, bleeding, technical failure, pancreatitis
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Hospital Colentina

Collaborators

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

Investigators

  • Principal Investigator: theodor voiosu, MD, PhD, Colentina Clinical Hospital, UMF Carol Davila Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 8, 2020

First Posted (Actual)

April 10, 2020

Study Record Updates

Last Update Posted (Actual)

June 7, 2022

Last Update Submitted That Met QC Criteria

June 4, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIERS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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