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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02570516
Other study ID # P140108
Secondary ID 2015-A00552-47
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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