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Ionizing Radiation During Endoscopic Procedures (ENDORAY Study)

Ionizing Radiation During Endoscopic Procedures: a Single-center, Prospective Study of Dose Reference Levels.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07009587
Acronym
ENDORAY
Enrollment
2782
Registered
2025-06-06
Start date
2018-06-01
Completion date
2021-12-31
Last updated
2025-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro-Intestinal Disorder

Brief summary

The primary objective of this prospective study was to describe the evolution of dose reference levels (DRLs) in a specialized French center during endoscopic procedures involving ionizing radiation and performed without a radiology technician. The secondary objective was to assess the influence of the operator on the recorded dose for each procedure.

Detailed description

This prospective study, approved by the Institutional Review Board (IRB) of the Groupement de Coopération Sanitaire Ramsay Santé (approval no. 2019-06-010), was conducted in the endoscopy unit of Jean Mermoz Hospital (Lyon, France). To standardize practices, all operators underwent blended training (3 hours of e-learning and 3 hours of hands-on training on the Shine Enhancer system), which was completed and validated on June 25, 2018. As per guidelines, the graphic (cine) mode was never used. Only the latest fluoroscopic images were printed and archived. The database includes all consecutive patients who underwent an endoscopic procedure between June 26, 2018, and December 31, 2021. Each report was retrospectively reviewed to confirm the therapeutic intention (intention-to-treat). Initially, only the type of procedure and the dose-area product (DAP) were recorded. From October 7, 2019, fluoroscopy time (FT) was also systematically collected. Six experienced endoscopists performed all procedures. The patient's position varied depending on the procedure, although most were performed in the supine position under general anesthesia. No radiologic technician was present during the procedures. The fluoroscopic system was entirely managed by the endoscopist, including all parameter adjustments (distance between patient and detector, use of pulsed vs continuous fluoroscopy, collimation, duration, etc.). Two mobile C-arm X-ray systems were used throughout the study: Siemens Arcadis and GE OEC Fluorostar, both under-couch systems.

Interventions

PROCEDUREEndoscopy

endoscopic procedure

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients aged 18 years or older, who have been informed of the research; * Patients who have undergone an endoscopic procedure under radiological control * Subjects for whom all data concerning the methods of exposure to ionizing radiation are available;

Exclusion criteria

* Patient under legal protection, guardianship, or curatorship; * Patient who has indicated their opposition to the use of their medical data (by completing and returning the opposition form that will be sent to them).

Design outcomes

Primary

MeasureTime frameDescription
dose reference levelPeriproceduralAssessment of dose reference levels (DRLs) with the Dose Area Product (DAP) collected for each procedure

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026