Interventional Reference Levels (IRL) in Digestive Endoscopy

NCT ID: NCT06363682

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-06-11

Brief Summary

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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

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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

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Each Endoscopic Intervention Using X-rays

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type PROCEDURE

endoscopic ultrasound

The use of endoscopic ultrasound in diverse situation with the necessity of using X rays

Intervention Type 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.

Intervention Type PROCEDURE

Colonoscopy

The diverse procedure in witch scopy is use during a colonoscopy

Intervention Type PROCEDURE

placement of a nasojejunal tube

placement of a nasojejunal tube for enteral nutritional support

Intervention Type PROCEDURE

Other Intervention Names

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ERCP + removal of a biliary stent ERCP + removal of a pancreatic stent ECRP + switch of a biliary stent ERCP + switch of a pancreatic stent ERCP + cholangioscopy + biopsy ERCP + clearance of a biliary stent ERCP + extraction of gallstone ERCP + placement of a biliary stent ERCP +placement of a pancreatic stent ERCP of the pancreatic duct + pancreatoscopy endoscopic ultrasound + bulbocholedocian stent endoscopic ultrasound + hepaticogastric stent cystogastrostomy with endoscopic ultrasound endoscopic ultrasound + ponction of a target endoscopic ultrasound +/- catheterization endoscopic ultrasound + gastroenterological anastomosis gastroscopy + removal of gastroduodenal stent gastroscopy + removal of oesophageal stent gastroscopy + switch of a oesophageal stent gastroscopy + placement' of a oesophageal stent gastroscopy + placement of a gastroduodenal stent gastroscopy + oesophageal dilatation gastroscopy + gastroduodenal dilatation colonoscopy + placement of a colic stent colonoscopy + dilatation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital University of Nancy

Nancy, Meurthe-et-Moselle, France

Site Status

Countries

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France

Central Contacts

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CHEVAUX Doctor CHEVAUX Jean-Baptiste, PhD

Role: CONTACT

+33 3 83 15 41 49

Facility Contacts

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MUNIER W Munier Wendy

Role: primary

+3383155457

Other Identifiers

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2023PI225

Identifier Type: -

Identifier Source: org_study_id

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