NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome

Lynch Syndrome Clinical Trial

— LYNCH-CHROMO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02570516
• Other study ID #: P140108
• Secondary ID: 2015-A00552-47
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: February 2018

Study information

• Verified date: September 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Neoplasms, Hereditary Nonpolyposis
• Lynch Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	CHRU de Tours - Hôpital Trousseau	Chambray-lès-Tours	Centre-Val De Loire
France	HCL - Hôpital Edouard-Herriot	Lyon	Auvergne-Rhône-Alpes
France	CHU Nantes - Hôtel-Dieu	Nantes	Pays De La Loire
France	AP-HP - Hôpital Cochin	Paris	Île-de-France
France	AP-HP - Hôpital Européen Georges-Pompidou	Paris
France	AP-HP - Hôpital Saint-Antoine	Paris	Île-de-France
France	Institut Gustave-Roussy	Villejuif	Île-de-France

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	ARC Foundation for Cancer Research

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Cost of each procedure (NBI vs Indigo carmine)	Evaluate the cost of each procedure including therapy.	Procedure time
Secondary	Duration of each procedure (NBI vs Indigo carmine)	Evaluate the duration of each procedure (with and without endoscopic therapy).	Procedure time
Secondary	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