Project PREVAM : Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy for the Detection of Adenomatous Polyps and Cancer in a High Risk Population

Conditions
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Adenomatous Polyps, Cancer

Intervention / Treatment
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* Device: Comparison of capsule endoscopy Pillcam II™ versus colonoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>On the same patient, we compare both methods (video-colonoscopy vs capsule endoscopy) | Device: Comparison of capsule endoscopy Pillcam II™ versus colonoscopy<br>* On the same patient, we compare both methods (video-colonoscopy vs capsule endoscopy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | The investigators want to know if the capsule endoscopie is more or less effective than colonoscopy to detect lesion or abdominal cancer. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores on the Visual Analog Scale | 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). | 7 days |