French Prospective Cohort of Innovative Endoscopic Interventions in Expert Centers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Effectiveness of diagnostic and therapeutic and/or innovative endoscopic techniques.
- Who it may be relevant to
- Registry conditions: Endoscopy, Innovative Procedures. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The creation of a multi-center French cohort pooling data from innovative endoscopies carried out in France every year would make it possible to produce excellent scientific results and analyze on a large scale the results of our current practices.
Detailed description
Diagnostic and therapeutic digestive endoscopy has been booming over the last 10 years. Many new techniques in digestive tract or hepato-bilio-pancreatic endoscopy are introduced every year. France is the Western country with the most technical skills in terms of the number of experts relative to the size of its territory, but is lagging far behind in terms of the promotion and reimbursement of these techniques by health insurance funds. France is also experiencing difficulties in centralizing health data from the thousands of endoscopies performed in the country every year. Pooling this data across the country, following the example of certain European and international partners (the Dutch, English and Australians), would make it easier to exploit data from innovative, sometimes rare or confidential digestive endoscopy procedures, and to justify their reimbursement once their usefulness has been confirmed through large-scale descriptive prospective studies associated with national multicenter publications.
The creation of a multi-center French cohort pooling data from innovative endoscopies carried out in France every year would make it possible to produce excellent scientific results and analyze on a large scale the results of our current practi
Interventions
- Other Effectiveness of diagnostic and therapeutic and/or innovative endoscopic techniques
Evaluate the effectiveness of diagnostic and therapeutic and/or innovative endoscopic techniques practiced in French expert centers over the next 10 years with the rate of technical success (procedure completed) and clinical success (cure) of the digestive pathology presented by the patient who indicated endoscopy without recourse to a new intervention (endoscopic or surgical) within 30 days of the procedure.
Primary outcome measures
- Evaluate the effectiveness of diagnostic, therapeutic and/or innovative endoscopic practiced in French expert centers over the next 10 years. [Time frame: 10 years]
Secondary outcome measures (5)
- Evaluate the safety of diagnostic and therapeutic and/or innovative endoscopic techniques performed in French expert centers over the next 10 years. [Time frame: 10 years]
- Evaluate the secondary failure rate [Time frame: 10 years]
- Evaluate operating time [Time frame: 10 years]
- Evaluate inter-operator variability in efficacy [Time frame: 10 years]
- Evaluate long-term efficacy [Time frame: 10 years]
Eligibility criteria
Inclusion criteria
- Patients \> 18 yo
- Patient able to give consent
- Patient with innovative endoscopy
Exclusion criteria
- Opposition to participation in the present project to be notified in the file
- Patient under court protection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- Chu Nimes — Nîmes
- Hôpital Européen Georges Pompidou AP-HP — Paris
Identifiers
NCT: NCT06589882 · LOCAL/2024/LC-01