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

NCT01184781 | Completed

• 1 other identifier: 10-PP-02
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Adenomatous Polyps; Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain Scores on the Visual Analog Scale

  7 days

Study Arms (1)

A

OTHER

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

Device: Comparison of capsule endoscopy Pillcam II™ versus colonoscopy

Interventions

Comparison of capsule endoscopy Pillcam II™ versus colonoscopy DEVICE

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

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (2)

Digestive department - Archet hospital

Nice, 06000, France

Location

Gastro entérology department

Sanremo, Italy

Location

Related Publications (1)

• Parodi A, Vanbiervliet G, Hassan C, Hebuterne X, De Ceglie A, Filiberti RA, Spada C, Conio M. Colon capsule endoscopy to screen for colorectal neoplasia in those with family histories of colorectal cancer. Gastrointest Endosc. 2018 Mar;87(3):695-704. doi: 10.1016/j.gie.2017.05.023. Epub 2017 May 26.

  PMID: 28554656 DERIVED

MeSH Terms

Conditions

Adenomatous Polyps; Neoplasms

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• HEBUTERNE Xavier, PU-PH

  Digestive department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: August 19, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: November 1, 2013
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

IT (1); FR (1)