Clinical trial · Interventional
Comparison Between Chromoendoscopy and Conventional Colonoscopy to Improve the Detection of Neoplasia in Patients With Ulcerative Colitis (UC)
Comparaison de la Chromo Endoscopie Virtuelle FICE (Fujinon Intelligent Chromoendoscopy) Avec la Coloscopie Conventionnelle Dans la détection de la Dysplasie Chez Patients Porteurs de Recto Colite ulcéro hémorragique (RCH).
- 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)
The primary endpoint of the study will be to compare the accuracy of two procedures (FICE with target biopsies only, versus conventional white light colonoscopy with recommended targeted and random biopsies) in the endoscopic surveillance of patient with long-standing UC. Accuracy will be measured based on the number of patients with confirmed neoplasia using each technique. The combined histological outcome following the two procedures will represent the gold-standard diagnosis for each patient. Secondary outcomes will be the number of patients with false-positive findings, the number of neoplastic lesions detected, the number of false-positive lesions per patient for each technique and the total time required for each procedure.
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 |
|---|---|---|---|
| Ulcerative Colitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional white light colonoscopy | Device | — | UNRESOLVED |
| FICE (Fujinon Intelligent Chromoendoscopy) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Conventional white light colonoscopy
- interventionNames
- Device: conventional white light colonoscopy
- type
- EXPERIMENTAL
- label
- B
- description
- Chromoendoscopy
- interventionNames
- Device: FICE (Fujinon Intelligent Chromoendoscopy)
Primary outcomes (1)
- measure
- The primary endpoint of the study will be to compare the accuracy of two procedures (FICE with target biopsies only, versus conventional white light colonoscopy)
- timeFrame
- 3 months between FICE and Conventional white light colonoscopy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Clinically and histologically verified UC * Disease duration ≥ 8 years * A Mayo score ≤ 8 with an endoscopic sub score ≤ 2 * CPAM affiliation * Able to give written informed consent to participate in the study Exclusion Criteria: * Known intraepithelial neoplasia or colorectal cancer or any other active malignancy * Previous colo-rectal surgery * Non-treatable coagulopathy or hemostatic dysfunction (prothrombin index \< 50% of control or/and partial thromboplastin time \> 50 seconds and/or thrombopenia \< 60000 / mm3) * Pregnancy * Inability to give informed consent
References
Publications (0)
Data not yet available