Adenomatous Polyps, Cancer
Conditions
Brief summary
The aim of the study is to perform a prospective, multicenter research comparing capsule endoscopy with the video colonoscopy in the detection of the adenomatous polyps and cancer specifically in a high risk population (sensibility, specificity, NPV, PPV and diagnostic accuracy). The investigators will used the Pillcam II™ colon capsule (second generation) and a high resolution colonoscope (with high definition). Both procedures will be perform in the same day with an adapted bowel preparation.
Interventions
DEVICEComparison of capsule endoscopy Pillcam II™ versus colonoscopy
On the same patient, we compare both methods (video-colonoscopy vs capsule endoscopy)
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years old * Patient with 40 years old and first degree relative affected by colo rectal cancer at age ≥ 60 ans * Patient with 40 years old or ten years before the age at affected disease in case or first deree relative colo rectal cancer before 60 years old. * Fecal occult blood test positive * Personal history of adenomatous polyps * Personnal history of acromegaly * Patient with social insurance * Persons already participating in another clinical trial.. * Signature of informed consent
Exclusion criteria
* Pregnancy or breast feeding woman * Déficience mentale du sujet rendant sa participation à l'essai impossible * Pacemaker or all electronic devices implanted * Patient with swallowing disorder, or digestive stricture know or suspected by the investigator * Previous history of intestinal surgery, radiotherapy or inflammatory bowel disease * Previous history of polyadenomatous congenital disease, Lynch syndrome * Intolerance with dompéridon and/or bisacodyl * Intolerance with oral intake of NaP, polyethylen glycol (PEG) or macrogol * Colonoscopy contre indication for anesthesiologic reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 7 days | The investigators want to know if the capsule endoscopie is more or less effective than colonoscopy to detect lesion or abdominal cancer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores on the Visual Analog Scale | 7 days | Presence of at least one polyp at capsule endoscopy and colonoscopy with both operators unaware of each other's findings until completion of the procedures. Comparison of the different class of size for all polyps Comparison of Kudo and Paris classification of the polyps at endoscopy capsule and colonoscopy Tolerance, pain and discomfort between the both procedure Acceptability of both procedure at day 1 and day 7 Accuracy of the localization of the polyp or the lesion at the capsule endosocpy comparated with the colonoscopy topography (Gold standard). |
Countries
France, Italy
Outcome results
None listed