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

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.

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Key information

Conditions

Adenomatous Polyps Adenoma Cancer Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Digestive department - Archet hospital, Nice, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparison of capsule endoscopy Pillcam II™ versus colonoscopy

Device

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

Primary outcomes

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 outcomes

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).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2013
First posted: Aug 19, 2010
Registry last updated: Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed