Chromoscopic Guided Endomicroscpy to Diagnose Colitis Associated Dysplasia

July 13, 2006 updated by: Johannes Gutenberg University Mainz

Diagnosis of Intraepithelial Neoplasia in Patients With Long Standing Ulcerative Colitis With Chromoscopic Guided Endomicroscopy

Timely diagnosis of intraepithelial neoplasias (premalignant condition)is of crucial importance for clinical management of ulcerative colitis. We assessed the value of combined chromoscopy and endomicroscopy for diagnosis of intraepithelial neoplasias in a randomised controlled trial.

Endomicroscopy is a new device which enables microscopy of the mucosal layer during ongoing colonoscopy. Chromoscopy means topical staining of mucosal surface to unmask areas of interest, which are subsequently examined with the endomicroscopic system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ulcerative colitis (UC) is an immune cell-mediated inflammatory bowel disease characterized by mucosal ulcerations, rectal bleeding, diarrhea, and abdominal pain. Patients with long standing UC face an increased risk for development of colitis associated colorectal cancer. Factors associated with increased risk for cancer development include the duration of the disease, extensive colonic involvement (pancolitis, backwash ileitis), primary sclerosing cholangitis and severe chronic active inflammation. Based on these observations, colonoscopic surveillance in patients with long-standing UC is highly recommended.

The main objective of surveillance colonoscopy in UC is to detect neoplasia at a surgically curative and preferably pre-invasive stage. However, in contrast to sporadic colorectal cancer, the growing pattern of neoplastic tissue in UC is often flat and multifocal. Therefore, significant lesions during conventional colonoscopy in UC are frequently overlooked. Chromoscopy with topically applied dyes such as methylene blue or indigo carmine facilitates the endoscopic detection of flat, circumscribed colitis associated neoplastic changes in UC. In fact, five controlled studies showed that the diagnostic yield for the detection of intraepithelial neoplasia (IN) using chromoscopy is higher as compared to conventional colonoscopy with random biopsies. Based on the above studies, chromoscopy has recently been considered for incorporation into US guidelines for surveillance of patients with long-standing UC. However, although this technique does allow identification of mucosal lesions, it is not suitable for accurate endoscopic diagnosis of intraepithelial neoplasias in UC due to the lack of cellular resolution and subsurface imaging. For endoscopy, novel techniques allowing accurate diagnoses during ongoing examination are highly desirable and may allow appropriate and immediate therapeutic manoeuvres (e.g. resection versus biopsy). Recently, a miniaturized confocal microscope has been developed integrated in the distal tip of a conventional colonoscope . This new diagnostic technology for gastrointestinal endoscopy, denoted confocal endomicroscopy, enables histological evaluation of the mucosal layer during ongoing colonoscopy. Furthermore, in patients screened for sporadic colorectal cancer, surface and subsurface analysis at cellular and subcellular resolution can be used to predict intraepithelial neoplasias (INs) with high accuracy. However, due to the time required for examination of large surface areas, this technique is not suitable for screening of the entire colonic surface in UC to detect neoplasias in flat mucosa.

In the present study, we employ chromoscopy to identify potential neoplastic lesions and combine this for the first time with endomicroscopy for the endoscopic diagnosis of colitis associated intraepithelial neoplasias in UC. Using such chromoscopy guided endomicroscopy we will ecaluate whether the diagnostic yield diagnosing IN can be significantly increased.

Study Type

Interventional

Enrollment

114

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • I. Med. Klinik, Johannes Gutenberg Universitaet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinically and histologically verified UC
  • Disease duration >8 years
  • Colitis Activity Index ≤8
  • Activity index of Truelove and Witts: mild

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
  • Known allergy to methylene blue or Fluorescein

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Histological proof of neoplastic tissue (Intraepithelial neoplasia or cancer)

Secondary Outcome Measures

Outcome Measure
Prediction of extent and severity of inflamed mucosa

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Investigators

  • Study Director: Peter R. Galle, MD PhD, Johannes Gutenberg University, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Study Completion

November 1, 2004

Study Registration Dates

First Submitted

July 13, 2006

First Submitted That Met QC Criteria

July 13, 2006

First Posted (Estimate)

July 14, 2006

Study Record Updates

Last Update Posted (Estimate)

July 14, 2006

Last Update Submitted That Met QC Criteria

July 13, 2006

Last Verified

August 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DE 000043385

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Clinical Trials on Endomicroscope

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe