NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome (LYNCH-CHROMO)

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Lynch Syndrome

Treatments

Procedure: Colonoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT02570516

2015-A00552-47 (Other Grant/Funding Number)

P140108

Details and patient eligibility

About

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

Full description

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.

Enrollment

141 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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)