Clinical Trial: NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Number of adenomas and / or adenocarcinoma detected during each procedure (NBI vs Indigo carmine) [ Time Frame: procedure time ]

The adenoma detection rate (number of adenoma and/or adenocarcinoma) of NBI and the additional adenoma detection rate of indigo carmine.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: September 30, 2015
Date Started: November 2015
Date Completion: December 2017
Last Updated: April 13, 2017
Last Verified: April 2017