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Not yet recruiting NCT06589882

French Prospective Cohort of Innovative Endoscopic Interventions in Expert Centers

Observational Endoscopy Innovative Procedures

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 →

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗