Interventional Reference Levels (IRL) in Digestive Endoscopy

NCT06363682 | Not Yet Recruiting

• 1 other identifier: 2023PI225
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Each Endoscopic Intervention Using X-rays

Keywords

scopy; X rays; digestive endoscopy; interventional reference levels

Outcome Measures

Primary Outcomes (1)

• To define IRL (interventional reference levels) adapted to each type of endoscopic procedure.

  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

  From enrollment to the end of data collection at 3 months

Secondary Outcomes (3)

• Application of regulatory texts

  From enrollment to the end of data collection at 3 months

• Assessment of patient radiation protection

  From enrollment to the end of data collection at 3 months

• Radiation protection assessment for workers

  From enrollment to the end of data collection at 3 months

Interventions

ERCP PROCEDURE

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

Also known as: 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 PROCEDURE

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

Also known as: 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 PROCEDURE

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.

Also known as: 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 PROCEDURE

The diverse procedure in witch scopy is use during a colonoscopy

Also known as: colonoscopy + placement of a colic stent, colonoscopy + dilatation

placement of a nasojejunal tube PROCEDURE

placement of a nasojejunal tube for enteral nutritional support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who have received an X-ray dose during an endoscopic procedure on one of the 22 private or public hopsitals in France.

You may qualify if:

• All patients who have received an X-ray dose during an endoscopic procedure

You may not qualify if:

• No X-rays produced
• Medical indication not in favour of the scopy procedure in view of the benefit/risk balance

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Hospital University of Nancy

Nancy, Meurthe-et-Moselle, 54000, France

Location

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde; Biopsy; Endoscopic Ultrasound-Guided Fine Needle Aspiration; Gastroscopy; Colonoscopy; Dilatation

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Investigative Techniques; Biopsy, Fine-Needle; Biopsy, Needle; Image-Guided Biopsy; Ultrasonography, Interventional; Ultrasonography; Endoscopy, Gastrointestinal

Central Study Contacts

CHEVAUX Doctor CHEVAUX Jean-Baptiste, PhD

CONTACT

+33 3 83 15 41 49; jb.chevaux@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: April 1, 2024
• Primary Completion: June 11, 2024
• Study Completion: June 11, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)