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

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

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

Study Overview

• Status: Completed
• Conditions: Lynch Syndrome
• Intervention / Treatment: Procedure: Colonoscopy

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: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • AP-HP - Hopital Europeen Georges-Pompidou
  • Auvergne-Rhône-Alpes
    • Lyon, Auvergne-Rhône-Alpes, France, 69003
      • HCL - Hôpital Edouard-Herriot
  • Centre-Val De Loire
    • Chambray-lès-Tours, Centre-Val De Loire, France, 37170
      • CHRU de Tours - Hopital Trousseau
  • Pays De La Loire
    • Nantes, Pays De La Loire, France, 44093
      • CHU Nantes - Hôtel-Dieu
  • Île-de-France
    • Paris, Île-de-France, France, 75014
      • AP-HP - Hôpital Cochin
    • Paris, Île-de-France, France, 75012
      • Ap-Hp - Hopital Saint-Antoine
    • Villejuif, Île-de-France, France, 94805
      • Institut Gustave-Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adenomas and / or adenocarcinoma detected during each procedure (NBI vs Indigo carmine)	The adenoma detection rate (number of adenoma and/or adenocarcinoma) of NBI and the additional adenoma detection rate of indigo carmine.	procedure time

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: ARC Foundation for Cancer Research
• Investigators: Principal Investigator: CHRISTOPHE CELLIER, MD, PHD, Hopital Europeen Georges Pompidou

Publications and helpful links

General Publications

• Cellier C, Perrod G, Colas C, Dhooge M, Saurin JC, Lecomte T, Coron E, Rahmi G, Savale C, Chaussade S, Bellanger J, Dray X, Benech N, Le Rhun M, Barbieux JP, Pereira H, Chatellier G, Samaha E. Back-to-Back Comparison of Colonoscopy With Virtual Chromoendoscopy Using a Third-Generation Narrow-Band Imaging System to Chromoendoscopy With Indigo Carmine in Patients With Lynch Syndrome. Am J Gastroenterol. 2019 Oct;114(10):1665-1670. doi: 10.14309/ajg.0000000000000386.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: October 5, 2015
• First Posted (Estimate): October 7, 2015

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 20, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Colonoscopy; Narrow band imaging; Indigo carmine chromoendoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Neoplasms; Neoplasms by Site; Disease; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Genetic Diseases, Inborn; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Neoplastic Syndromes, Hereditary; DNA Repair-Deficiency Disorders; Syndrome; Colorectal Neoplasms, Hereditary Nonpolyposis
• Other Study ID Numbers: P140108; 2015-A00552-47 (Other Grant/Funding Number: ANSM)