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OpenTrials
Completed

NCT Number: NCT04341909

Trainee Involvement in ERCP Risk Score

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Colentina Clinical Hospital

Bucharest, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERCP

Procedure

endoscopic retrograde cholangiopancreatography

Primary outcomes

  1. any procedure related adverse outcome

    Time frame: 30 days

    including but not limited to cholangitis, perforation, bleeding, technical failure, pancreatitis

Sponsors and collaborators

Lead sponsor

Clinical Hospital Colentina

Other

Collaborators

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

Registry information

Acronym: TIERS

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 10, 2020
Registry last updated
Jun 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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