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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00659867

Enrollment

182

Registered

2008-04-16

Start date

2008-12-31

Completion date

2016-09-30

Last updated

2016-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis, Endomicroscopy, Chromoendoscopy, Confocal colonoscope, Surveillance colonoscopy

Brief summary

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.

Interventions

DEVICEPENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes

chromoscopy-guided endomicroscopy with targeted biopsies

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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	Day 1 (colonoscopy)

Secondary

Measure	Time frame
Efficacy of chromoscopy-guided endomicroscopy in the detection of lesions and in the reduction of the number of biopsies. Time needed for the examination will be measured and compared between the two groups.	Day 1 (colonoscopy)

Countries

Germany, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026