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

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ClinicalTrials.gov Identifier: NCT02570516
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : May 28, 2018
Sponsor:
Collaborator:
ARC Foundation for Cancer Research
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE September 30, 2015
First Posted Date  ICMJE October 7, 2015
Last Update Posted Date May 28, 2018
Actual Study Start Date  ICMJE November 2015
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
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 Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02570516 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome
Official Title  ICMJE 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Lynch Syndrome
Intervention  ICMJE Procedure: Colonoscopy
A double colonoscopy is performed in a back-to-back design using NBI chromoendoscopy then indigo carmine in each patient.
Study Arms  ICMJE
  • Active Comparator: Indigo carmine colonoscopy
    Colonoscopy using indigo carmine is performed in second place
    Intervention: Procedure: Colonoscopy
  • Experimental: NBI colonoscopy
    Colonoscopy using NBI is performed in first place
    Intervention: Procedure: Colonoscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2018)
141
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2015)
140
Actual Study Completion Date  ICMJE February 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02570516
Other Study ID Numbers  ICMJE P140108
2015-A00552-47 ( Other Grant/Funding Number: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE ARC Foundation for Cancer Research
Investigators  ICMJE
Principal Investigator: CHRISTOPHE CELLIER, MD, PHD Hopital europeen Georges Pompidou
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP