Clinical trial · Interventional
Chromoendoscopy for Dysplasia Detection in Chronic Inflammatory Bowel Disease
Randomized Controlled Trial (RCT) to Compare Dysplasia Detection Rate in Colonoscopy Without Chromoendoscopy Versus Colonoscopy With Chromoendoscopy in Detecting Dysplasia in Ulcerative Colitis and Crohn's Colitis Patients.
- 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)
Patients with longstanding ulcerative colitis or crohn's disease in the large bowel have an increased risk of developing cancer. The purpose of this study is to determine if visualizing of the mucosa in details using a dye spray (indigo-carmine) will result in detection of more abnormalities than conventional colonoscopy without dye spray.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Crohn's Colitis | — | UNRESOLVED | — |
| Ulcerative Colitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopy with Indigo-Carmine chromoendoscopy | Procedure | — | UNRESOLVED |
| Conventional white-light colonoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Colonoscopy with chromoendoscopy
- description
- Colonoscopy with chromoendoscopy using 0.2-0.5% Indigo-Carmine solution sprayed in the whole colon and rectum plus 32 random biopsies plus biopsies from suspicious areas
- interventionNames
- Procedure: Colonoscopy with Indigo-Carmine chromoendoscopy
- type
- ACTIVE_COMPARATOR
- label
- Conventional colonoscopy
- description
- White light colonoscopy plus 32 random biopsies plus biopsies from suspicious areas
- interventionNames
- Procedure: Conventional white-light colonoscopy
Primary outcomes (1)
- measure
- Prevalence of dysplastic lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients with ulcerative colitis or Crohn's colitis satisfying criteria for surveillance colonoscopy: * Ulcerative colitis, extensive \> 8 years OR Crohn's colitis involving ≥ 1/3 of colon/rectum * history of PSC or * history of previous dysplasia on colon biopsies or * family history of colon cancer in first degree relative Exclusion Criteria: * Patients who decline to participate * Unable to give informed consent * Increased risk of bleeding (i.e. Warfarin, bleeding disorders, Clopidogrel)
References
Publications (1)
- DERIVEDAlexandersson B, Hamad Y, Andreasson A, Rubio CA, Ando Y, Tanaka K, Ichiya T, Rezaie R, Schmidt PT. High-Definition Chromoendoscopy Superior to High-Definition White-Light Endoscopy in Surveillance of Inflammatory Bowel Diseases in a Randomized Trial. Clin Gastroenterol Hepatol. 2020 Aug;18(9):2101-2107. doi: 10.1016/j.cgh.2020.04.049. Epub 2020 Apr 27. PMID 32353535