Clinical trial NCT02570516: NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome
Official title: Comparison of Colonoscopy With Virtual Chromoendoscopy Using 3rd Generation NBI System to Chromoendoscopy With Indigo Carmine in Lynch Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lynch Syndrome
Keywords: Indigo carmine chromoendoscopy
Narrow band imaging
Colonoscopy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: ARC Foundation for Cancer Research
First posted: 2015-10-07
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility 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)

Primary outcomes:
measure: Number of adenomas and / or adenocarcinoma detected during each procedure (NBI vs Indigo carmine)
timeFrame: procedure time
Secondary outcomes:
measure: All neoplastic lesions detected during colonoscopy
timeFrame: procedure time
measure: Cost of each procedure (NBI vs Indigo carmine)
timeFrame: Procedure time
measure: Duration of each procedure (NBI vs Indigo carmine)
timeFrame: Procedure time
measure: Number of subject with adverse events as mesure of safety.
timeFrame: One month after colonoscopy
Other outcomes:
Locations:
city: Lyon
country: France
facility: HCL - Hôpital Edouard-Herriot
state: Auvergne-Rhône-Alpes
city: Chambray-lès-Tours
country: France
facility: CHRU de Tours - Hôpital Trousseau
state: Centre-Val De Loire
city: Nantes
country: France
facility: CHU Nantes - Hôtel-Dieu
state: Pays De La Loire
city: Paris
country: France
facility: AP-HP - Hôpital Européen Georges-Pompidou
city: Paris
country: France
facility: AP-HP - Hôpital Saint-Antoine
state: Île-de-France
city: Paris
country: France
facility: AP-HP - Hôpital Cochin
state: Île-de-France
city: Villejuif
country: France
facility: Institut Gustave-Roussy
state: Île-de-France
Study officials:
affiliation: Hopital europeen Georges Pompidou
name: CHRISTOPHE CELLIER, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.