Clinical trial NCT06589882: French Prospective Cohort of Innovative Endoscopic Interventions in Expert Centers
Official title: French Prospective Cohort of Innovative Endoscopic Interventions in Expert Centers
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Endoscopy
Innovative Procedures
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing innovative diagnostic or therapeutic endoscopy who do not express opposition to the use of their data from examination reports. The aim of the cohort is to provide follow-up data on innovative procedures in digestive endoscopy, in order to justify their value. Patients included in the CoPPInE innovative digestive endoscopy cohort will be considered as undergoing innovative endoscopy

Brief summary: 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

Eligibility criteria: Inclusion Criteria:

* Patients \&gt; 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

Primary outcomes:
measure: Evaluate the effectiveness of diagnostic, therapeutic and/or innovative endoscopic practiced in French expert centers over the next 10 years.
timeFrame: 10 years
Secondary outcomes:
measure: Evaluate the safety of diagnostic and therapeutic and/or innovative endoscopic techniques performed in French expert centers over the next 10 years.
timeFrame: 10 years
measure: Evaluate the secondary failure rate
timeFrame: 10 years
measure: Evaluate operating time
timeFrame: 10 years
measure: Evaluate inter-operator variability in efficacy
timeFrame: 10 years
measure: Evaluate long-term efficacy
timeFrame: 10 years
Other outcomes:
Locations:
city: Nimes
country: France
facility: Chu Nimes
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou AP-HP
Study officials:
References: