NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome

Not Applicable

Completed

• Conditions: Lynch Syndrome
• Interventions: Procedure: Colonoscopy

• Registration Number: NCT02570516
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-10-05
• Study First Posted: 2015-10-07
• Study Start: 2015-11
• Primary Completion: 2017-12
• Study Completion: 2018-02
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-20
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Indigo carmine colonoscopy	Colonoscopy	Colonoscopy using indigo carmine is performed in second place
NBI colonoscopy	Colonoscopy	Colonoscopy using NBI is performed in first place

Primary Outcome Measures

Name	Time	Method
Number of adenomas and / or adenocarcinoma detected during each procedure (NBI vs Indigo carmine)	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

Name	Time	Method
Number of subject with adverse events as mesure of safety.	One month after colonoscopy	Followed a month post colonoscopy to evaluate the occurrence of undesirable events
All neoplastic lesions detected during colonoscopy	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.
Duration of each procedure (NBI vs Indigo carmine)	Procedure time	Evaluate the duration of each procedure (with and without endoscopic therapy).
Cost of each procedure (NBI vs Indigo carmine)	Procedure time	Evaluate the cost of each procedure including therapy.

Trial Locations

Locations (7)

Institut Gustave-Roussy; 🇫🇷 Villejuif, Île-de-France, France

AP-HP - Hôpital Saint-Antoine; 🇫🇷 Paris, Île-de-France, France

CHU Nantes - Hôtel-Dieu; 🇫🇷 Nantes, Pays De La Loire, France

CHRU de Tours - Hôpital Trousseau; 🇫🇷 Chambray-lès-Tours, Centre-Val De Loire, France

AP-HP - Hôpital Européen Georges-Pompidou; 🇫🇷 Paris, France

HCL - Hôpital Edouard-Herriot; 🇫🇷 Lyon, Auvergne-Rhône-Alpes, France

AP-HP - Hôpital Cochin; 🇫🇷 Paris, Île-de-France, France