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

Primary Purpose

Lynch Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Colonoscopy
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lynch Syndrome focused on measuring Indigo carmine chromoendoscopy, Narrow band imaging, Colonoscopy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • HCL - Hôpital Edouard-Herriot
  • CHRU de Tours - Hôpital Trousseau
  • CHU Nantes - Hôtel-Dieu
  • AP-HP - Hôpital Européen Georges-Pompidou
  • AP-HP - Hôpital Saint-Antoine
  • AP-HP - Hôpital Cochin
  • Institut Gustave-Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Indigo carmine colonoscopy

NBI colonoscopy

Arm Description

Colonoscopy using indigo carmine is performed in second place

Colonoscopy using NBI is performed in first place

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Cost of each procedure (NBI vs Indigo carmine)
Evaluate the cost of each procedure including therapy.
Duration of each procedure (NBI vs Indigo carmine)
Evaluate the duration of each procedure (with and without endoscopic therapy).
Number of subject with adverse events as mesure of safety.
Followed a month post colonoscopy to evaluate the occurrence of undesirable events

Full Information

First Posted
September 30, 2015
Last Updated
September 20, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
ARC Foundation for Cancer Research
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1. Study Identification

Unique Protocol Identification Number
NCT02570516
Brief Title
NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome
Acronym
LYNCH-CHROMO
Official Title
Comparison of Colonoscopy With Virtual Chromoendoscopy Using 3rd Generation NBI System to Chromoendoscopy With Indigo Carmine in Lynch Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
ARC Foundation for Cancer Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lynch Syndrome
Keywords
Indigo carmine chromoendoscopy, Narrow band imaging, Colonoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indigo carmine colonoscopy
Arm Type
Active Comparator
Arm Description
Colonoscopy using indigo carmine is performed in second place
Arm Title
NBI colonoscopy
Arm Type
Experimental
Arm Description
Colonoscopy using NBI is performed in first place
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy
Intervention Description
A double colonoscopy is performed in a back-to-back design using NBI chromoendoscopy then indigo carmine in each patient.
Primary Outcome Measure Information:
Title
Number of adenomas and / or adenocarcinoma detected during each procedure (NBI vs Indigo carmine)
Description
The adenoma detection rate (number of adenoma and/or adenocarcinoma) of NBI and the additional adenoma detection rate of indigo carmine.
Time Frame
procedure time
Secondary Outcome Measure Information:
Title
All neoplastic lesions detected during colonoscopy
Description
Collect the number, size, location, endoscopic (Paris Classification) and anatomo-pathologic aspect (adenoma, hyperplastic polyp, adenocarcinoma) of all detected lesions with their respective prevalence.
Time Frame
procedure time
Title
Cost of each procedure (NBI vs Indigo carmine)
Description
Evaluate the cost of each procedure including therapy.
Time Frame
Procedure time
Title
Duration of each procedure (NBI vs Indigo carmine)
Description
Evaluate the duration of each procedure (with and without endoscopic therapy).
Time Frame
Procedure time
Title
Number of subject with adverse events as mesure of safety.
Description
Followed a month post colonoscopy to evaluate the occurrence of undesirable events
Time Frame
One month after colonoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CHRISTOPHE CELLIER, MD, PHD
Organizational Affiliation
Hopital europeen Georges Pompidou
Official's Role
Principal Investigator
Facility Information:
Facility Name
HCL - Hôpital Edouard-Herriot
City
Lyon
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
69003
Country
France
Facility Name
CHRU de Tours - Hôpital Trousseau
City
Chambray-lès-Tours
State/Province
Centre-Val De Loire
ZIP/Postal Code
37170
Country
France
Facility Name
CHU Nantes - Hôtel-Dieu
City
Nantes
State/Province
Pays De La Loire
ZIP/Postal Code
44093
Country
France
Facility Name
AP-HP - Hôpital Européen Georges-Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
AP-HP - Hôpital Saint-Antoine
City
Paris
State/Province
Île-de-France
ZIP/Postal Code
75012
Country
France
Facility Name
AP-HP - Hôpital Cochin
City
Paris
State/Province
Île-de-France
ZIP/Postal Code
75014
Country
France
Facility Name
Institut Gustave-Roussy
City
Villejuif
State/Province
Île-de-France
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31498154
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.
Results Reference
derived

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NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome

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