Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas (G-EYE-ADR)

Institut Paoli-Calmettes

Status: Completed

Conditions: Colorectal Adenoma

Treatments: Device: G-EYE first and standard colonoscope; Device: standard colonoscope first and G-EYE

Study type: Interventional

Funder types: Other

Identifiers

NCT03961893

G-EYE-ADR-IPC 2016-023

2018-A03292-53 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 164 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

Arm A: Standard colonoscopy then colonoscopy with G-EYE

Experimental group

Description:

Arm A: Standard colonoscopy then colonoscopy with G-EYE

Treatment:

Device: standard colonoscope first and G-EYE

Arm B: G-EYE colonoscopy then standard colonoscopy

Experimental group

Description:

Arm B: G-EYE colonoscopy then standard colonoscopy

Treatment:

Device: G-EYE first and standard colonoscope