COmparison of White Light and Linked COlor Imaging for Detection of RIght COlon Polyps

Colonoscopy Clinical Trial

— COCORICO  

Official title:

COmparison of White Light and Linked COlor Imaging for Detection of RIght COlon Polyps: A Multi Center Prospective Randomized Tandem Colonoscopy Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04112563
• Other study ID #: ID-RCB 2019-A01287-50
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: March 2021
• Source: Société Française d'Endoscopie Digestive
• Contact: David KARSENTI, MD
• Phone: +33 1 45 48 65 65
• Email: karsenti[@]club-internet.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon
• Colon Polyp
• Colonic Polyps
• Colonoscopy
• Polyps

Intervention

Procedure:
• exploration in white light (WLI)
Exploration of the right colon done in white light (WLI)
• Exploration in LCI
Exploration of the right colon in linked color imaging (LCI)

Locations

Country	Name	City	State
France	Clinique Paris-Bercy	Charenton-le-Pont

Sponsors (1)

Lead Sponsor	Collaborator
Société Française d'Endoscopie Digestive

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of missed adenomas during the first exploration of the right colon	Number of polyps diagnosed on the second exploration and not removed (because not diagnosed) during the first exploration	1 day
Secondary	The factors influencing these missed polyp rates	Time of exploration (in seconds)	1 day
Secondary	The factors influencing these missed polyp rates	Boston scale (0 to 9)	1 day
Secondary	The characteristics of the missed polyps	Size in millimeters	1 day
Secondary	The characteristics of the missed polyps	type : Adenoma polyp / Advanced neoplasia polyp / Serrated polyp / Hyperplastic polyp	1 day
Secondary	Adenoma Detection Rate (ADR)	given by the first exploration technique decided by randomization: percentage of colonoscopy with one or more adenoma of the right colon	1 day
Secondary	Advanced Neoplasia Detection Rate (ANDR)	given by the first exploration technique decided by randomization: percentage of colonoscopy with one or more advanced neoplasia of the right colon	1 day
Secondary	Serrated Polyp Detection Rate (SPDR)	given by the first exploration technique decided by randomization: percentage of colonoscopy with one or more serrated polyp of the right colon	1 day