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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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

Condition or disease Intervention/treatment Phase
Lynch Syndrome Procedure: Colonoscopy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Colonoscopy With Virtual Chromoendoscopy Using 3rd Generation NBI System to Chromoendoscopy With Indigo Carmine in Lynch Patients.
Actual Study Start Date : November 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Active Comparator: Indigo carmine colonoscopy
Colonoscopy using indigo carmine is performed in second place
Procedure: Colonoscopy
A double colonoscopy is performed in a back-to-back design using NBI chromoendoscopy then indigo carmine in each patient.

Experimental: NBI colonoscopy
Colonoscopy using NBI is performed in first place
Procedure: Colonoscopy
A double colonoscopy is performed in a back-to-back design using NBI chromoendoscopy then indigo carmine in each patient.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Cost of each procedure (NBI vs Indigo carmine) [ Time Frame: Procedure time ]
    Evaluate the cost of each procedure including therapy.

  3. Duration of each procedure (NBI vs Indigo carmine) [ Time Frame: Procedure time ]
    Evaluate the duration of each procedure (with and without endoscopic therapy).

  4. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570516


Locations
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France
HCL - Hôpital Edouard-Herriot
Lyon, Auvergne-Rhône-Alpes, France, 69003
CHRU de Tours - Hôpital Trousseau
Chambray-lès-Tours, Centre-Val De Loire, France, 37170
CHU Nantes - Hôtel-Dieu
Nantes, Pays De La Loire, France, 44093
AP-HP - Hôpital Européen Georges-Pompidou
Paris, France, 75015
AP-HP - Hôpital Saint-Antoine
Paris, Île-de-France, France, 75012
AP-HP - Hôpital Cochin
Paris, Île-de-France, France, 75014
Institut Gustave-Roussy
Villejuif, Île-de-France, France, 94805
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
ARC Foundation for Cancer Research
Investigators
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Principal Investigator: CHRISTOPHE CELLIER, MD, PHD Hopital europeen Georges Pompidou

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02570516     History of Changes
Other Study ID Numbers: P140108
2015-A00552-47 ( Other Grant/Funding Number: ANSM )
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Indigo carmine chromoendoscopy
Narrow band imaging
Colonoscopy

Additional relevant MeSH terms:
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Syndrome
Colorectal Neoplasms, Hereditary Nonpolyposis
Disease
Pathologic Processes
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases