Clinical trial · Interventional
NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome
Comparison of Colonoscopy With Virtual Chromoendoscopy Using 3rd Generation NBI System to Chromoendoscopy With Indigo Carmine in Lynch Patients.
NCT02570516CI-TRIAL-00040757LYNCH-CHROMOcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study compares two colonoscopy techniques (with Narrow Band Imaging versus with indigo carmine chromoendoscopy) in patients having Lynch Syndrome
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lynch Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Indigo carmine colonoscopy
- description
- Colonoscopy using indigo carmine is performed in second place
- interventionNames
- Procedure: Colonoscopy
- type
- EXPERIMENTAL
- label
- NBI colonoscopy
- description
- Colonoscopy using NBI is performed in first place
- interventionNames
- Procedure: Colonoscopy
Primary outcomes (1)
- measure
- Number of adenomas and / or adenocarcinoma detected during each procedure (NBI vs Indigo carmine)
- timeFrame
- procedure time
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDCellier 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. PMID 31498154