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Completed

NCT Number: NCT02570516

NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome

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

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Key information

Conditions

Lynch Syndrome Colonic Diseases Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Repair-Deficiency Disorders Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Intestinal Diseases Intestinal Neoplasms Metabolic Diseases Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HCL - Hôpital Edouard-Herriot, Lyon, Auvergne-Rhône-Alpes, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

colonoscopy

Procedure

A double colonoscopy is performed in a back-to-back design using NBI chromoendoscopy then indigo carmine in each patient.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • ARC Foundation for Cancer Research

Registry information

Official study title

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

Acronym: LYNCH-CHROMO

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Oct 7, 2015
Registry last updated
Sep 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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