Interventional Reference Levels (IRL) in Digestive Endoscopy (EndoscopX)

April 9, 2024 updated by: Central Hospital, Nancy, France

Scopy uses X-rays and is not without risk (deterministic and stochastic effects) for the patient and the nursing staff present in the room at the time of an endoscopic procedure requiring its use: its use must be reasoned with a benefit/risk balance in favour of carrying out the interventional procedure. In France, there is currently no multicentre study exploring the radiation doses used for each type of endoscopic procedure.

Main objective: To define IRL (interventional reference levels) adapted to each type of endoscopic procedure.

Secondary objective(s) :

  • Application of regulatory texts
  • Assessment of patient radiation protection
  • Radiation protection assessment for workers

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Prospective data collection using an e-CRF available via Easymedstat. Data completed during the endoscopy procedure Completion of a questionnaire by the practitioner who performed the procedure afterwards, including the scopy doses used during the procedure, the type of scopy, the type of intention-to-treat

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

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

Study Contact

Study Locations

  • France
    • Meurthe-et-Moselle
      • Nancy, Meurthe-et-Moselle, France, 54000
        • Hospital University of Nancy
        • Contact:
        • Principal Investigator:
          • CHEVAUX JB Doctor CHEVAUX Jean-Baptiste, PhD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients who have received an X-ray dose during an endoscopic procedure on one of the 22 private or public hopsitals in France.

Description

Inclusion Criteria:

  • All patients who have received an X-ray dose during an endoscopic procedure

Exclusion Criteria:

  • No X-rays produced
  • Medical indication not in favour of the scopy procedure in view of the benefit/risk balance

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To define IRL (interventional reference levels) adapted to each type of endoscopic procedure.
Time Frame: From enrollment to the end of data collection at 3 months
IRL is the mean for all endoscopic procedure using scopy, it is calculated by multiplying the PDS in Gy.cm2 with the time during witch the patient as been expose to Xrays during the procedure
From enrollment to the end of data collection at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Application of regulatory texts
Time Frame: From enrollment to the end of data collection at 3 months
yes or no variable : the good delivery of information to the patient about the use of X rays during the procedure ;up-to-date radiation protection training for staff; up-to-date radiation protection training for patient
From enrollment to the end of data collection at 3 months
Assessment of patient radiation protection
Time Frame: From enrollment to the end of data collection at 3 months
yes or no variable : optimising X-ray doses
From enrollment to the end of data collection at 3 months
Radiation protection assessment for workers
Time Frame: From enrollment to the end of data collection at 3 months
yes or no variable : Wearing ACTIVE and/or PASSIVE dosimeters in accordance with regulations; Wearing personal protective equipment
From enrollment to the end of data collection at 3 months

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

June 11, 2024

Study Completion (Estimated)

June 11, 2024

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023PI225

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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