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

Centre Hospitalier Universitaire de Nice

Status: Completed

Conditions: Adenomatous Polyps; Cancer

Treatments: Device: Comparison of capsule endoscopy Pillcam II™ versus colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01184781

10-PP-02

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

A

Other group

Description:

On the same patient, we compare both methods (video-colonoscopy vs capsule endoscopy)

Treatment:

Device: Comparison of capsule endoscopy Pillcam II™ versus colonoscopy