Lynch SyndromeLYNCH-CHROMONCT02570516
NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome
A study testing Colonoscopy in people with Lynch Syndrome, run by Assistance Publique - Hôpitaux de Paris at 7 sites in France.
Trial summary
This study compares two colonoscopy techniques (with Narrow Band Imaging versus with indigo carmine chromoendoscopy) in patients having Lynch Syndrome Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lynch Syndrome
- What is being tested?
- Colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 7 sitesFrance
- Study dates
- Nov 2015to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHRU de Tours - Hôpital Trousseau
Chambray-lès-Tours, Centre-Val de Loire, 37170
HCL - Hôpital Edouard-Herriot
Lyon, Auvergne-Rhône-Alpes, 69003
CHU Nantes - Hôtel-Dieu
Nantes, Pays de la Loire Region, 44093
AP-HP - Hôpital Européen Georges-Pompidou
Paris, 75015
AP-HP - Hôpital Saint-Antoine
Paris, Île-de-France Region, 75012
AP-HP - Hôpital Cochin
Paris, Île-de-France Region, 75014
Institut Gustave-Roussy
Villejuif, Île-de-France Region, 94805
About this study
Official title: Comparison of Colonoscopy With Virtual Chromoendoscopy Using 3rd Generation NBI System to Chromoendoscopy With Indigo Carmine in Lynch Patients.
This study compares two colonoscopy techniques (with Narrow Band Imaging versus with indigo carmine chromoendoscopy) in patients having Lynch Syndrome
Read the 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.
- Conditions
- Lynch Syndrome
- Being tested
- Colonoscopy
- Keywords
- Indigo carmine chromoendoscopy, Narrow band imaging, Colonoscopy
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
A double colonoscopy is performed in a back-to-back design using NBI chromoendoscopy then indigo carmine in each patient.
| Study group | Role | What they receive |
|---|---|---|
| Indigo carmine colonoscopy | Active comparator | Colonoscopy using indigo carmine is performed in second place Receives: Procedure: Colonoscopy |
| NBI colonoscopy | Experimental | Colonoscopy using NBI is performed in first place Receives: Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: procedure time
Secondary outcomes (4)
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.
Measured: procedure time
Cost of each procedure (NBI vs Indigo carmine)
Evaluate the cost of each procedure including therapy.
Measured: Procedure time
Duration of each procedure (NBI vs Indigo carmine)
Evaluate the duration of each procedure (with and without endoscopic therapy).
Measured: Procedure time
Number of subject with adverse events as mesure of safety.
Followed a month post colonoscopy to evaluate the occurrence of undesirable events
Measured: One month after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lynch SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- ARC Foundation for Cancer Research
- Responsible party
- Sponsor
- Investigators
- CHRISTOPHE CELLIER, MD, PHD, Principal investigator, Hopital europeen Georges Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570516
- Sponsor's protocol ID
- P140108
- Other IDs
- 2015-A00552-47
- Acronym
- LYNCH-CHROMO
- Status last verified
- Sep 2019
- First submitted
- 30 Sep 2015
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31498154
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Colonoscopy With Virtual Chromoendoscopy Using 3rd Generation NBI System to Chromoendoscopy With Indigo Carmine in Lynch Patients.
- ClinicalTrials.gov ID
- NCT02570516
- Acronym / sponsor ID
- LYNCH-CHROMO / P140108
- Conditions
- Lynch Syndrome
- Keywords
- Indigo carmine chromoendoscopy, Narrow band imaging, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- ARC Foundation for Cancer Research
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indigo carmine colonoscopy | Active comparator | Procedure: ColonoscopyColonoscopy using indigo carmine is performed in second place |
| NBI colonoscopy | Experimental | Procedure: ColonoscopyColonoscopy using NBI is performed in first place |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColonoscopyA double colonoscopy is performed in a back-to-back design using NBI chromoendoscopy then indigo carmine in each patient. | Procedure or surgery | Indigo carmine colonoscopy, NBI colonoscopy |
Primary outcome
Number of adenomas and / or adenocarcinoma detected during each procedure (NBI vs Indigo carmine)
Time frame: procedure time
The adenoma detection rate (number of adenoma and/or adenocarcinoma) of NBI and the additional adenoma detection rate of indigo carmine.
4 secondary outcomes
All neoplastic lesions detected during colonoscopy
Time frame: procedure time
Cost of each procedure (NBI vs Indigo carmine)
Time frame: Procedure time
Duration of each procedure (NBI vs Indigo carmine)
Time frame: Procedure time
Number of subject with adverse events as mesure of safety.
Time frame: One month after colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Derived from this study: PubMed 31498154Cellier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHRISTOPHE CELLIER, MD, PHD principal investigator
Hopital europeen Georges Pompidou
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy in people with Lynch Syndrome, run by Assistance Publique - Hôpitaux de Paris at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adenomas and / or adenocarcinoma detected during each procedure (NBI vs Indigo carmine) (time frame: procedure time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02570516, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.