Back to resultsProject PREVAM : Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy
Primary Purpose
Adenomatous Polyps, Cancer
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Comparison of capsule endoscopy Pillcam II™ versus colonoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Adenomatous Polyps
Eligibility Criteria
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
Sites / Locations
- Digestive department - Archet hospital
- Gastro entérology department
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
A
Arm Description
On the same patient, we compare both methods (video-colonoscopy vs capsule endoscopy)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT01184781
First Posted
July 26, 2010
Last Updated
September 5, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT01184781
Brief Title
Project PREVAM : Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy
Official Title
Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy for the Detection of Adenomatous Polyps and Cancer in a High Risk Population
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 2010 (Actual)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomatous Polyps, Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Other
Arm Description
On the same patient, we compare both methods (video-colonoscopy vs capsule endoscopy)
Intervention Type
Device
Intervention Name(s)
Comparison of capsule endoscopy Pillcam II™ versus colonoscopy
Intervention Description
On the same patient, we compare both methods (video-colonoscopy vs capsule endoscopy)
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
The investigators want to know if the capsule endoscopie is more or less effective than colonoscopy to detect lesion or abdominal cancer.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Pain Scores on the Visual Analog Scale
Description
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).
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HEBUTERNE Xavier, PU-PH
Organizational Affiliation
Digestive department
Official's Role
Study Director
Facility Information:
Facility Name
Digestive department - Archet hospital
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Gastro entérology department
City
San Remo
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
28554656
Citation
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.
Results Reference
derived
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Project PREVAM : Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy
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