Clinical trial NCT03961893: Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas
Official title: Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Adenoma
Keywords: colonoscopy
g-eye
adenomas
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 164
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, single-phase, two-stage, randomized phase II study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)
timeFrame: Colonoscopy time
Secondary outcomes:
measure: Rate of missed advanced adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)
timeFrame: Colonoscopy time
measure: Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in male and female
timeFrame: Colonoscopy time
measure: Rate of complications
timeFrame: Colonoscopy time and 1 month after
measure: Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in positive fetal immunochemical test (FIT+) subgroup
timeFrame: Colonoscopy time
measure: Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in FIT+ subgroup
timeFrame: Colonoscopy time
measure: G-EYE assistance for endoscope stabilization
timeFrame: Colonoscopy time
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches Du Rhone
Study officials:
affiliation: Institut Paoli-Calmettes
name: Jean-Philippe RATONE, MD
role: PRINCIPAL_INVESTIGATOR
References: