Each Endoscopic Intervention Using X-raysEndoscopXNCT06363682
Interventional Reference Levels (IRL) in Digestive Endoscopy
An observational study of Each Endoscopic Intervention Using X-rays, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Each Endoscopic Intervention Using X-rays
- What is being tested?
- ERCP, endoscopic ultrasound and gastroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2024to 11 Jun 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients who have received an X-ray dose during an endoscopic procedure
Who cannot join
- No X-rays produced
- Medical indication not in favour of the scopy procedure in view of the benefit/risk balance
Trial locations and contacts
1 site in 1 country.
France1 site
Hospital University of Nancy
Nancy, Meurthe-et-Moselle, 54000
MUNIER W Munier Wendy, +3383155457, w.munier@chru-nancy.fr
CHEVAUX JB Doctor CHEVAUX Jean-Baptiste, PhD
About this study
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
Read the 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
- Being tested
- ERCP, endoscopic ultrasound, gastroscopy, Colonoscopy, placement of a nasojejunal tube
- Keywords
- scopy, X rays, digestive endoscopy, interventional reference levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
Also called 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 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
endoscopic ultrasoundProcedure or surgery
Also called endoscopic ultrasound + bulbocholedocian stent, endoscopic ultrasound + hepaticogastric stent, cystogastrostomy with endoscopic ultrasound, endoscopic ultrasound + ponction of a target
The use of endoscopic ultrasound in diverse situation with the necessity of using X rays
gastroscopyProcedure or surgery
Also called gastroscopy + removal of gastroduodenal stent, gastroscopy + removal of oesophageal stent, gastroscopy + switch of a oesophageal stent, gastroscopy + placement' of a oesophageal stent
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.
ColonoscopyProcedure or surgery
Also called colonoscopy + placement of a colic stent, colonoscopy + dilatation
The diverse procedure in witch scopy is use during a colonoscopy
placement of a nasojejunal tubeProcedure or surgery
placement of a nasojejunal tube for enteral nutritional support
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of data collection at 3 months
Secondary outcomes (3)
Application of regulatory texts
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
Measured: From enrollment to the end of data collection at 3 months
Assessment of patient radiation protection
yes or no variable : optimising X-ray doses
Measured: From enrollment to the end of data collection at 3 months
Radiation protection assessment for workers
yes or no variable : Wearing ACTIVE and/or PASSIVE dosimeters in accordance with regulations; Wearing personal protective equipment
Measured: From enrollment to the end of data collection at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 Apr 2024 (estimated)
- Primary completion11 Jun 2024 (estimated)
- Study completion11 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Each Endoscopic Intervention Using X-raysStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363682
- Sponsor's protocol ID
- 2023PI225
- Acronym
- EndoscopX
- Status last verified
- Feb 2024
- First submitted
- 9 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Reference Levels (IRL) in Digestive Endoscopy
- ClinicalTrials.gov ID
- NCT06363682
- Acronym / sponsor ID
- EndoscopX / 2023PI225
- Keywords
- scopy, X rays, digestive endoscopy, interventional reference levels
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 11 Jun 2024 (estimated)
- Study completion
- 11 Jun 2024 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients who have received an X-ray dose during an endoscopic procedure
Key exclusion criteria (2 listed)
- No X-rays produced
- Medical indication not in favour of the scopy procedure in view of the benefit/risk balance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERCPAlso: ERCP + removal of a biliary stent, ERCP + removal of a pancreatic stent, ECRP + switch of a biliary stent, ERCP + switch of a pancreatic stentERCP 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 or surgery | – |
| endoscopic ultrasoundAlso: endoscopic ultrasound + bulbocholedocian stent, endoscopic ultrasound + hepaticogastric stent, cystogastrostomy with endoscopic ultrasound, endoscopic ultrasound + ponction of a targetThe use of endoscopic ultrasound in diverse situation with the necessity of using X rays | Procedure or surgery | – |
| gastroscopyAlso: gastroscopy + removal of gastroduodenal stent, gastroscopy + removal of oesophageal stent, gastroscopy + switch of a oesophageal stent, gastroscopy + placement' of a oesophageal stentThe 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 or surgery | – |
| ColonoscopyAlso: colonoscopy + placement of a colic stent, colonoscopy + dilatationThe diverse procedure in witch scopy is use during a colonoscopy | Procedure or surgery | – |
| placement of a nasojejunal tubeplacement of a nasojejunal tube for enteral nutritional support | Procedure or surgery | – |
Primary outcome
To define IRL (interventional reference levels) adapted to each type of endoscopic procedure.
Time frame: 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
3 secondary outcomes
Application of regulatory texts
Time frame: From enrollment to the end of data collection at 3 months
Assessment of patient radiation protection
Time frame: From enrollment to the end of data collection at 3 months
Radiation protection assessment for workers
Time frame: From enrollment to the end of data collection at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Each Endoscopic Intervention Using X-rays, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CHEVAUX Doctor CHEVAUX Jean-Baptiste, PhD (+33 3 83 15 41 49, jb.chevaux@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To define IRL (interventional reference levels) adapted to each type of endoscopic procedure. (time frame: From enrollment to the end of data collection at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.