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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Ulcerative Colitis

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Outcome 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

Outcome Time Frame:

Day 1 (colonoscopy)

Safety Issue:

No

Principal Investigator

Ralf Kiesslich, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johannes Gutenberg-Universität Mainz, I. Med. Klinik

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

2006-09

NCT ID:

NCT00659867

Start Date:

December 2008

Completion Date:

April 2012

Related Keywords:

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

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