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

C

Central Hospital, Nancy, France

Status

Not yet enrolling

Conditions

Each Endoscopic Intervention Using X-rays

Treatments

Procedure: endoscopic ultrasound
Procedure: Colonoscopy
Procedure: placement of a nasojejunal tube
Procedure: ERCP
Procedure: gastroscopy

Study type

Observational

Funder types

Other

Identifiers

NCT06363682
2023PI225

Details and patient eligibility

About

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

Full 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

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

CHEVAUX Doctor CHEVAUX Jean-Baptiste, PhD

Data sourced from clinicaltrials.gov

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