NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome

Study Overview
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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

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.

Official Title
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Comparison of Colonoscopy With Virtual Chromoendoscopy Using 3rd Generation NBI System to Chromoendoscopy With Indigo Carmine in Lynch Patients.

Conditions
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Lynch Syndrome

Intervention / Treatment
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* Procedure: Colonoscopy


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Indigo carmine colonoscopy<br>Colonoscopy using indigo carmine is performed in second place | Procedure: Colonoscopy<br>* A double colonoscopy is performed in a back-to-back design using NBI chromoendoscopy then indigo carmine in each patient.<br>|
| Experimental: NBI colonoscopy<br>Colonoscopy using NBI is performed in first place | Procedure: Colonoscopy<br>* A double colonoscopy is performed in a back-to-back design using NBI chromoendoscopy then indigo carmine in each patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adenomas and / or adenocarcinoma detected during each procedure (NBI vs Indigo carmine) | The adenoma detection rate (number of adenoma and/or adenocarcinoma) of NBI and the additional adenoma detection rate of indigo carmine. | procedure time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All neoplastic lesions detected during colonoscopy | Collect the number, size, location, endoscopic (Paris Classification) and anatomo-pathologic aspect (adenoma, hyperplastic polyp, adenocarcinoma) of all detected lesions with their respective prevalence. | procedure time | 
| Cost of each procedure (NBI vs Indigo carmine) | Evaluate the cost of each procedure including therapy. | Procedure time | 
| Duration of each procedure (NBI vs Indigo carmine) | Evaluate the duration of each procedure (with and without endoscopic therapy). | Procedure time | 
| Number of subject with adverse events as mesure of safety. | Followed a month post colonoscopy to evaluate the occurrence of undesirable events | One month after colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indigo carmine chromoendoscopy, Narrow band imaging, Colonoscopy