NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-02-28

Brief Summary

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This study compares two colonoscopy techniques (with Narrow Band Imaging versus with indigo carmine chromoendoscopy) in patients having Lynch Syndrome

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Detailed Description

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Chromoendoscopy using indigo carmine dye is recommended every 1 to 2 years in patients having Lynch Syndrome (LS). However, it is a time-consuming procedure, requiring a prior learning and has an additional cost, the reason why it is not yet systematically practiced in all endoscopy centers. The "Narrow Band Imaging" (NBI) is a recent virtual chromoendoscopy technique using optical filters at the light source of the endoscope to highlight the vascular structures of the mucosa by pressing a button. NBI is currently used to better characterize dysplasia lesions in the esophageal, gastric, and colon mucosa. A new generation (3rd generation) of NBI is currently available on some endoscopes, it can deliver more brightness and contrast, and could allow for better detection of flat lesions. Until today, no study has directly compared colonic chromoendoscopy with Indigo carmine to virtual chromoendoscopy with NBI (3rd generation) in LS patients. The hypothesis that this research aims to verify is that the new generation NBI system might do at least as well as indigo carmine in colonic adenoma detection in LS. This study aims to compare colonoscopy with virtual chromoendoscopy using 3rd generation NBI system to chromoendoscopy with indigo carmine in LS patients, in a back-to-back, prospective non inferiority design, in which all patients will have both techniques in the following order: NBI first followed by Indigo carmine.

Conditions

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Lynch Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Indigo carmine colonoscopy

Colonoscopy using indigo carmine is performed in second place

Group Type ACTIVE_COMPARATOR

Colonoscopy

Intervention Type PROCEDURE

A double colonoscopy is performed in a back-to-back design using NBI chromoendoscopy then indigo carmine in each patient.

NBI colonoscopy

Colonoscopy using NBI is performed in first place

Group Type EXPERIMENTAL

Colonoscopy

Intervention Type PROCEDURE

A double colonoscopy is performed in a back-to-back design using NBI chromoendoscopy then indigo carmine in each patient.

Interventions

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Colonoscopy

A double colonoscopy is performed in a back-to-back design using NBI chromoendoscopy then indigo carmine in each patient.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Lynch Syndrome with an identified mutation in one of the genes MutL Homolog 1 (MLH1), MutL Homolog 2 (MLH2), MutS homolog6 (MSH6), PMS2 or epithelial cellular adhesion molecule (EpCAM)
* Age between 18 and 80
* Indication of a screening colonoscopy

Exclusion Criteria

* Any sign of intestinal occlusion contra-indicating bowel preparation
* History of total or subtotal colectomy
* Any serious medical condition contra-indicating colonoscopy under general anesthesia
* Pregnant or breast feeding women
* Any coagulation disorder contra-indicating biopsies or endoscopic resections
* Any history of hypersensitivity to indigo carmine
* Adults subject to a legal protection measure (guardianship or curatorship)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No