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Confocal Laser Endomicroscopy Findings in Patients With Proctosigmoiditis Before and After Initiation of Treatment

NCT01684514 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2016-08-17

No results posted yet for this study

Summary

Confocal laser endomicroscopy (CLE) is a novel method in evaluation of microscopic structures in vivo. The examination is carried out with a confocal laser endomicroscope, which is either part of the endoscope (manufactured by Pentax) or probe based (manufactured by Cellvizio). Hereby, all parts of the gastrointestinal (GI) tract can be examined. The method has potential to replace conventional microscopy and the dynamic nature of the procedure allows visualization of structures and cellular processes in almost real-time. This provides us with a potentially new diagnostic tool with a promising future. To date only a few studies have been published on inflammatory bowel disease (IBD) and in the literature high-quality research is still lacking.

The project consists of a blinded prospective observation and methodology study including inter- and intra-observation of patients with proctitis before and after initiation of local treatment.

Hypothesis: CLE can be used to assess the degree and extend of acute and chronic inflammation and treatment response in patients with ulcerative colitis and is a sensitive supplementary to conventional diagnostics.

Conditions

  • Colitis, Ulcerative

Interventions

DEVICE

Confocal laser endomicroscopy

Within recent years a new approach was introduced, wherein the microscopic structures of the intestinal mucous can be evaluated continuously in vivo during the endoscopic procedure. The technique is called confocal laser endomicroscopy (CLE). CLE functions by means of a laser device, which is inserted or build into an endoscope, and used as an illuminator of the lining of a small area and at a precise depth. The tissue is first added with fluorescence by intravenous administration. The reflection of the mucosa is captured in a focused area and magnified by which a two-dimensional image of mucosal microscopic structures is formed. This provides us with an "optical biopsy", which can be compared with a similar microscopic image.

Sponsors & Collaborators

  • Herlev Hospital

    lead OTHER

Principal Investigators

  • John G Karstensen, MD · Gastroenheden, Herlev Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-12-31
Completion
2015-02-28

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01684514 on ClinicalTrials.gov