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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00552-47 | Other Grant/Funding Number | ANSM |
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| Name | Class |
|---|---|
| ARC Foundation for Cancer Research | OTHER |
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This study compares two colonoscopy techniques (with Narrow Band Imaging versus with indigo carmine chromoendoscopy) in patients having Lynch Syndrome
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indigo carmine colonoscopy | Active Comparator | Colonoscopy using indigo carmine is performed in second place |
|
| NBI colonoscopy | Experimental | Colonoscopy using NBI is performed in first place |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy | Procedure | A double colonoscopy is performed in a back-to-back design using NBI chromoendoscopy then indigo carmine in each patient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cost of each procedure (NBI vs Indigo carmine) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CHRISTOPHE CELLIER, MD, PHD | Hopital europeen Georges Pompidou | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HCL - Hôpital Edouard-Herriot | Lyon | Auvergne-Rhône-Alpes | 69003 | France | ||
| CHRU de Tours - Hôpital Trousseau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31498154 | Derived | 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. |
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| ID | Term |
|---|---|
| D003123 | Colorectal Neoplasms, Hereditary Nonpolyposis |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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Evaluate the cost of each procedure including therapy. |
| Procedure time |
| Duration of each procedure (NBI vs Indigo carmine) | Evaluate the duration of each procedure (with and without endoscopic therapy). | Procedure time |
| 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 |
| Chambray-lès-Tours |
| Centre-Val de Loire |
| 37170 |
| France |
| CHU Nantes - Hôtel-Dieu | Nantes | Pays de la Loire Region | 44093 | France |
| AP-HP - Hôpital Européen Georges-Pompidou | Paris | 75015 | France |
| AP-HP - Hôpital Saint-Antoine | Paris | Île-de-France Region | 75012 | France |
| AP-HP - Hôpital Cochin | Paris | Île-de-France Region | 75014 | France |
| Institut Gustave-Roussy | Villejuif | Île-de-France Region | 94805 | France |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |