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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01184781
• Other study ID #: 10-PP-02
• Status: Completed
• Phase: N/A
• Start date: August 2010
• Est. completion date: November 2013

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2013
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenomatous Polyps
• Cancer
• Polyps

Intervention

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

Locations

Country	Name	City	State
France	Digestive department - Archet hospital	Nice
Italy	Gastro entérology department	San Remo

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Countries where clinical trial is conducted

France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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