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Completed

NCT Number: NCT04112563

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Paris-Bercy

Charenton-le-Pont, 94220, France

About this study

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:

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

  • History of recto-colonic resection
  • Inadequate preparation (none under Boston score <2)
  • Patient referred for resection of a known polyp
  • Inflammatory Bowel Disease
  • family polyposis
  • Score: ASA 4, ASA 5
  • Pregnant woman
  • Patient with coagulation abnormalities preventing polyp resection: TP <50%, Platelets <50000 / mm3, effective anticoagulation in progress, clopidogrel in progress
  • Patient unable to personally consent
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exploration in white light (WLI)

Procedure

Exploration of the right colon done in white light (WLI)

Exploration in LCI

Procedure

Exploration of the right colon in linked color imaging (LCI)

Primary outcomes

  1. the number of missed adenomas during the first exploration of the right colon

    Time frame: 1 day

    Number of polyps diagnosed on the second exploration and not removed (because not diagnosed) during the first exploration

Secondary outcomes

  1. The factors influencing these missed polyp rates

    Time frame: 1 day

    Time of exploration (in seconds)

  2. The factors influencing these missed polyp rates

    Time frame: 1 day

    Boston scale (0 to 9)

  3. The characteristics of the missed polyps

    Time frame: 1 day

    Size in millimeters

  4. The characteristics of the missed polyps

    Time frame: 1 day

    type : Adenoma polyp / Advanced neoplasia polyp / Serrated polyp / Hyperplastic polyp

  5. Adenoma Detection Rate (ADR)

    Time frame: 1 day

    given by the first exploration technique decided by randomization: percentage of colonoscopy with one or more adenoma of the right colon

  6. Advanced Neoplasia Detection Rate (ANDR)

    Time frame: 1 day

    given by the first exploration technique decided by randomization: percentage of colonoscopy with one or more advanced neoplasia of the right colon

  7. Serrated Polyp Detection Rate (SPDR)

    Time frame: 1 day

    given by the first exploration technique decided by randomization: percentage of colonoscopy with one or more serrated polyp of the right colon

Sponsors and collaborators

Lead sponsor

Société Française d'Endoscopie Digestive

Other

Registry information

Official study title

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

Acronym: COCORICO

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 2, 2019
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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