NCT06363682

Interventional Reference Levels (IRL) in Digestive Endoscopy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Each Endoscopic Intervention Using X-rays

Interventions

Type	Name	Description
PROCEDURE	ERCP	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
PROCEDURE	endoscopic ultrasound	The use of endoscopic ultrasound in diverse situation with the necessity of using X rays
PROCEDURE	gastroscopy	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.
PROCEDURE	Colonoscopy	The diverse procedure in witch scopy is use during a colonoscopy
PROCEDURE	placement of a nasojejunal tube	placement of a nasojejunal tube for enteral nutritional support

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-06-11
• Completion: 2024-06-11
• First posted: 2024-04-12
• Last updated: 2024-04-12

Locations

1 site across 1 country: France