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

Overview

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.

Full Title of Study: “Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy for the Detection of Adenomatous Polyps and Cancer in a High Risk Population”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2010

Interventions

  • Device: Comparison of capsule endoscopy Pillcam II™ versus colonoscopy
    • On the same patient, we compare both methods (video-colonoscopy vs capsule endoscopy)

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability
    • Time Frame: 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 Measures

  • Pain Scores on the Visual Analog Scale
    • Time Frame: 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Nice
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • HEBUTERNE Xavier, PU-PH, Study Director, Digestive department

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.