Clinical trial NCT04112563: COmparison of White Light and Linked COlor Imaging for Detection of RIght COlon Polyps
Official title: COmparison of White Light and Linked COlor Imaging for Detection of RIght COlon Polyps: A Multi Center Prospective Randomized Tandem Colonoscopy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenoma Colon
Colon Polyp
Colonoscopy
Lead sponsor: Société Française d'Endoscopie Digestive
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 686
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: the patient will be randomized and included in one of two groups: WLI-LCI group: a first exploration of the right colon will be done in white light (WLI) then a second exploration will be done in LCI LCI-WLI group: a first exploration of the right colon will be done in LCI and a second exploration will be done in white light (WLI)
Primary purpose: DIAGNOSTIC

Brief summary: Comparison of the number of adenomas missed by the first exploration of the right colon by LCI (linked color imaging) or by white light during a colonoscopy, according to the order of randomization.

Detailed description: All patients consecutively admitted for routine colonoscopy will be included in this prospective randomized crossover study. After randomization, a first exploration of the right colon will be performed in linked color imaging (LCI) or white light imaging (WLI) depending of the randomization. Every polyp will be resected as soon it will be detected. After this first examination, colon will be explored a second time with a light system different from the one used for the first exploration. If a polyp will be detected during the second exploration, it will be counted as a polyp missed by the first exploration method.

A- Inclusion criteria:

1. Patient consecutively admitted to one of the endoscopy units for routine colonoscopy (screening, positive FIT, personal or family history of polyp or cancer, symptoms)
2. Patient whose age is greater than or equal to 18 years and less than 90 years
3. Score: ASA 1, ASA 2, ASA 3
4. No participation in another clinical study
5. Signed informed consent

Exclusion criteria:

History of recto-colic resection Inadequate preparation (none under Boston score \<2) Patient referred for resection of a polyp in place, known IBD (inflammatory bowel disease) or known polyposis

B- Exclusion criteria:

1. History of recto-colonic resection
2. Inadequate preparation (none under Boston score \<2)
3. Patient referred for resection of a known polyp
4. Inflammatory Bowel Disease
5. family polyposis
6. Score: ASA 4, ASA 5
7. Pregnant woman
8. Patient with coagulation abnormalities preventing polyp resection: TP \<50%, Platelets \<50000 / mm3, effective anticoagulation in progress, clopidogrel in progress
9. Patient unable to personally consent
10. No signed informed consent

Purposes of the study:

Compare, when exploring the number of adenomas missed by the first exploration of the right colon by LCI or by white light, according to the order of randomization.

Evaluation criteria :

Main criterion:

- Missed right colon adenomas by first exploration in LCI-WLI and WLI-LCI groups

Secondary criteria

* Rate of polyps missed by the first exploration
* Serrated polyp rate missed by the first exploration
* Advanced adenoma rate missed by the first exploration
* Comparison of ADR, SPDR, given by the first exploration technique decided by randomization

Number of patients:

The expected rate of "missed adenomas" of the colon is about 20%, based on published data. Considering as relevant an 8% reduction in this rate of "missed adenomas" of the right colon by the LCI, the expected rate for LCI is therefore 12%.

With a risk of the first species of 5% (bilateral test), a power of 80%, 329 patients per group should be included in the study. Taking into account the rate lost to follow-up of 5%, we expect a total of 700 patients.

Duration of the study:

1-2 years

Eligibility criteria: Inclusion Criteria:

* Patient consecutively admitted for routine colonoscopy

Exclusion Criteria:

* History of recto-colic resection
* Inadequate preparation (none under Boston score \<2)
* Patient referred for resection of a known polyp
* known Inflammatory Bowel Disease (IBD) or known polyposis

Primary outcomes:
measure: the number of missed adenomas during the first exploration of the right colon
timeFrame: 1 day
Secondary outcomes:
measure: The factors influencing these missed polyp rates
timeFrame: 1 day
measure: The factors influencing these missed polyp rates
timeFrame: 1 day
measure: The characteristics of the missed polyps
timeFrame: 1 day
measure: The characteristics of the missed polyps
timeFrame: 1 day
measure: Adenoma Detection Rate (ADR)
timeFrame: 1 day
measure: Advanced Neoplasia Detection Rate (ANDR)
timeFrame: 1 day
measure: Serrated Polyp Detection Rate (SPDR)
timeFrame: 1 day
Other outcomes:
Locations:
city: Charenton-le-Pont
country: France
facility: Clinique Paris-Bercy
Study officials:
affiliation: Société Française d'Endoscopie Digestive
name: David KARSENTI, MD
role: PRINCIPAL_INVESTIGATOR
References: