Each Endoscopic Intervention Using X-rays
Conditions
Keywords
scopy, X rays, digestive endoscopy, interventional reference levels
Brief summary
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
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
Interventions
PROCEDUREERCP
ERCP of the biliary duct ou the pancreatic duct, with or without the use of a stent, in a context of gallstone or tumor or other
PROCEDUREendoscopic ultrasound
The use of endoscopic ultrasound in diverse situation with the necessity of using X rays
PROCEDUREgastroscopy
The diverse procedure in witch scopy is use in orders to place or switch or remove an oesophageal or gastroduodenal stent during a gastroscopy. Or for oesophageal or gastroduodenal dilatation.
PROCEDUREColonoscopy
The diverse procedure in witch scopy is use during a colonoscopy
PROCEDUREplacement of a nasojejunal tube
placement of a nasojejunal tube for enteral nutritional support
Sponsors
Central Hospital, Nancy, France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To define IRL (interventional reference levels) adapted to each type of endoscopic procedure. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Application of regulatory texts | 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 |
| Assessment of patient radiation protection | From enrollment to the end of data collection at 3 months | yes or no variable : optimising X-ray doses |
| Radiation protection assessment for workers | 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 |
Countries
France
Contacts
Primary ContactCHEVAUX Doctor CHEVAUX Jean-Baptiste, PhD
Outcome results
None listed