Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas

Not Applicable

Completed

• Conditions: Colorectal Adenoma
• Interventions: Device: standard colonoscope first and G-EYE; Device: G-EYE first and standard colonoscope

• Registration Number: NCT03961893
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

Colonoscopy is the gold standard for colorectal cancer prevention by allowing the resection of superficial colorectal adenomas or adenocarcinomas. This protection, more effective in the left colon than in the right colon, is imperfect and there are some adenomas and cancers omitted during colonoscopy. The G-EYE colonoscope equipped with an integrated distal balloon would better unfold the haustrations and stabilize the endoscope. Thus, the detection rate of adenomas would be improved by this better vision. The main objective of this study is to confirm that the use of the G-EYE colonoscope allows better detection of adenomatous polyps, decrease the rate of omitted adenomes and then is more effective.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-22
• Study First Posted: 2019-05-23
• Study Start: 2020-01-21
• Status Verified: 2023-05
• Primary Completion: 2023-05-19
• Study Completion: 2023-06-19
• Last Update Submitted: 2023-06-22
• Last Update Posted: 2023-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

1. Indication of complete colonoscopy for classic indications (bleeding, abdominal pain, transit disorders) or for family and personal antecedents of adenomas or colorectal cancers with the need for endoscopic control,
2. FIT + test (current blood test for stool used for mass screening in France), PET-CT fixation,
3. Consent of participation signed,
4. Affiliation to a social security scheme, or beneficiary of such a scheme.

Exclusion Criteria

1. Non-optimal preparation (boston score <7 or segment <2),
2. Adenomatous polyposis, familial or assimilated (juvenile, etc.),
3. Pregnant or likely to be pregnant (without effective contraception) or breastfeeding,
4. Patient in emergency or deprived of liberty or placed under the authority of a tutor,
5. Patient considered geographically socially or psychologically unable to comply with the study procedure and the medical follow-up.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Standard colonoscopy then colonoscopy with G-EYE	standard colonoscope first and G-EYE	Arm A: Standard colonoscopy then colonoscopy with G-EYE
Arm B: G-EYE colonoscopy then standard colonoscopy	G-EYE first and standard colonoscope	Arm B: G-EYE colonoscopy then standard colonoscopy

Primary Outcome Measures

Name	Time	Method
Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)	Colonoscopy time	Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections

Secondary Outcome Measures

Name	Time	Method
Rate of missed advanced adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)	Colonoscopy time	Rate between the number of advanced adenomas detected by the second examination and the number of advanced adenomas detected by the two inspections
Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in male and female	Colonoscopy time	Rate between the number of detected adenomas with each endoscope and the number of colonoscopies performed in male and female
Rate of complications	Colonoscopy time and 1 month after	Global and for each arm
Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in positive fetal immunochemical test (FIT+) subgroup	Colonoscopy time	Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections in FIT+ subgroup
Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in FIT+ subgroup	Colonoscopy time	Rate between the number of detected adenomas with each endoscope and the number of colonoscopies performed in FIT+ subgroup
G-EYE assistance for endoscope stabilization	Colonoscopy time	Yes or no

Trial Locations

Locations (1)

Institut Paoli Calmettes; 🇫🇷 Marseille, Bouches Du Rhone, France