Colon Cancer Clinical Trial
Official title:
Prospective Study for Evaluating Colon Polyp Histology With in Vivo Probe Based Confocal Laser Endomicroscopy
Chromoendoscopy (that involves spraying of dyes over the colonic mucosa) combined with
magnification has been utilized for polyp histology identification. Pit patterns on the
surface of polyps described by Kudo et al have been shown to have a high diagnostic accuracy
in differentiating the polyp types (18, 19). NBI, that is also referred to as "electronic
chromoendoscopy" is another technique that has been evaluated for polyp histology
identification by highlighting the superficial mucosal and vascular architecture (15, 20,
21). pCLE is another novel addition to the technologies aiming to accomplish in vivo
histologic diagnosis with a high degree of accuracy. The pCLE system has three major
components (Mauna Kea Technologies, Paris, France). The first is the confocal miniprobe made
of approximately thirty thousand optical fibers bundled together and terminated by a distal
microsystem. The images obtained have a lateral resolution of 1µm, an axial resolution of 10
µm and a maximum field of view of 240 µm. The depth of observation is from 55 to 65 µm. The
miniprobe tip diameter is 2.5 mm and can be passed through the accessory channel of any
standard endoscope. The second is the laser scanning unit (excitation wavelength - 488 nm)
that combines the functions of laser light illumination and rapid laser scanning, enabling a
frame rate up to 12 images per second and signal detection. The third is the control and
acquisition software for real time image reconstruction, immediate sequences display and
post-procedure analysis and editing tools. Once an area of interest (e.g. a polyp) is
identified, 5 ml of 10% fluorescein sodium is injected intravenously; the confocal probe is
passed through the accessory channel of the endoscope and placed against the lesion to
obtain several high-quality images and video sequences. In a study by Buchner et al from the
Mayo Clinic, Jacksonville, (22) this system was used to evaluate confocal images of 37
polyps from 25 patients in a blinded fashion without the knowledge of their histologic
diagnosis or endoscopic appearance. The investigators developed the following criteria that
were suggestive of neoplastic polyps: villiform pattern, nuclear characteristics -
oval/irregular nuclear shape and increased number of nuclei. These features had a
sensitivity of 82.6%, specificity of 92.9% and accuracy of 86.5% for the characterization of
neoplastic polyps. Similarly, Meining et al (23) have also evaluated criteria for
differentiating neoplastic from benign lesions in the colon with encouraging results.
The investigators hypothesize that pCLE will have a high rate for accurate characterization
of polyp histology real time during colonoscopy
Status | Not yet recruiting |
Enrollment | 70 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - referral for screening and/or surveillance colonoscopy and the ability to provide informed consent. Exclusion Criteria: - prior surgical resection of any portion of colon, prior history of colon cancer, history of inflammatory bowel disease, use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure, poor general condition or any other reason to avoid prolonged procedure time, history of polyposis syndrome or HNPCC, inability to give informed consent, inadequate bowel preparation, allergy to fluorescein, pregnancy, and renal insufficiency. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening
Country | Name | City | State |
---|---|---|---|
United States | Veterans Affairs Medical Center | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
Midwest Biomedical Research Foundation | American Society for Gastrointestinal Endoscopy |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The predicted histology of polyps based on the confocal images and videos | The predicted histology of polyps based on the confocal images and videos and the correlation with actual histology for accuracy of prediction will be the primary outcome. | 2 years | No |
Secondary | The inter-observer variability in polyp histology prediction based on the confocal images and videos of polyps | the inter-observer variability in polyp histology prediction based on the confocal images and videos of polyps (by kappa statistics). | 2 yaers | No |
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