This study compares two colonoscopy techniques (with Narrow Band Imaging versus with indigo carmine chromoendoscopy) in patients having Lynch Syndrome
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
141
A double colonoscopy is performed in a back-to-back design using NBI chromoendoscopy then indigo carmine in each patient.
HCL - Hôpital Edouard-Herriot
Lyon, Auvergne-Rhône-Alpes, France
CHRU de Tours - Hôpital Trousseau
Chambray-lès-Tours, Centre-Val de Loire, France
CHU Nantes - Hôtel-Dieu
Nantes, Pays de la Loire Region, France
AP-HP - Hôpital Européen Georges-Pompidou
Paris, France
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.
Time frame: procedure time
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.
Time frame: procedure time
Cost of each procedure (NBI vs Indigo carmine)
Evaluate the cost of each procedure including therapy.
Time frame: Procedure time
Duration of each procedure (NBI vs Indigo carmine)
Evaluate the duration of each procedure (with and without endoscopic therapy).
Time frame: Procedure time
Number of subject with adverse events as mesure of safety.
Followed a month post colonoscopy to evaluate the occurrence of undesirable events
Time frame: One month after colonoscopy
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AP-HP - Hôpital Saint-Antoine
Paris, Île-de-France Region, France
AP-HP - Hôpital Cochin
Paris, Île-de-France Region, France
Institut Gustave-Roussy
Villejuif, Île-de-France Region, France