Clinical trial · Interventional
Endomicroscopy in Ulcerative Colitis
Chromoscopy-guided Endomicroscopy With the PENTAX EC-3870CIFK / EC-3870CILK Confocal Colonoscopes for the Detection of Intraepithelial Neoplasias in Subjects With Long Standing Ulcerative Colitis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment problems
Summary
Brief summary (as posted)
This is a confirmatory, multicentric, prospective, randomized, controlled, single-blind study in subjects with long standing ulcerative colitis in clinical remission with indication for surveillance colonoscopy. The patients are examined with the PENTAX EC-3870CIFK and EC-3870CILK confocal colonoscopes either by chromoscopy-guided endomicroscopy with targeted biopsies or by standard endoscopy with random and targeted biopsies. The aim is to investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard endoscopy with respect to detection of intraepithelial neoplasia (IN) and to compare the proportion of patients with at least 1 IN detected by chromoscopy-guided endomicroscopy versus standard endoscopy.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Chromoscopy-guided endomicroscopy with targeted biopsies
- interventionNames
- Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- Standard endoscopy with random and targeted biopsies
- interventionNames
- Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes
Primary outcomes (1)
- measure
- The primary objective is to investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard endoscopy with respect to detection of IN and to compare the proportion of patients with at least one IN
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent must be available before any trial-related procedures * Male and female patients aged 18 years and older * Clinically and histologically verified UC * Duration or Colitis ulcerosa \>8 years (date of first diagnosis) * Colitis Activity Index ≤ 8 * Activity index of Truelove and Witts: mild * Ability of subject to understand character and individual consequences of clinical trial * For women with childbearing potential, adequate contraception. Exclusion Criteria: * Known intraepithelial neoplasia or colorectal cancer * Coagulopathy (Prothrombin time \<50% of control, Partial thromboplastin time \>50 s) * Impaired renal function (Creatinine \>1.2 mg/dL) * Pregnancy or breast feeding * Inability to obtain informed consent * Active GI Bleeding * Known allergy to methylene blue or fluorescein * Participation in other clinical trials within the last 4 weeks
References
Publications (1)
- BACKGROUNDHurlstone DP, Kiesslich R, Thomson M, Atkinson R, Cross SS. Confocal chromoscopic endomicroscopy is superior to chromoscopy alone for the detection and characterisation of intraepithelial neoplasia in chronic ulcerative colitis. Gut. 2008 Feb;57(2):196-204. doi: 10.1136/gut.2007.131359. PMID 18192453