Prospective Study for Evaluating Colon Polyp Histology With in Vivo Probe Based Confocal Laser Endomicroscopy

NCT01214031 | Unknown

• 1 other identifier: AR0005
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colon Polyps; Adenomatous Polyps; Colon Cancer

Keywords

Confocal laser endomicroscope; Adenomatous polyps; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The inter-observer variability in polyp histology prediction based on the confocal images and videos of polyps

  2 yaers

Study Arms (1)

Confocal Laser Endomicroscopy Arm

OTHER

Confocal laser endomicroscopy (CLE) is another novel imaging tool for enabling histopathologic diagnosis in vivo during endoscopy. Specially designed confocal endoscopes have the confocal laser microscope integrated to the distal tip of the conventional endoscope. This provide images at a cellular level that have been shown to have a high sensitivity, specificity and accuracy.

Device: Confocal laser endomicroscopy (CLE)

Interventions

Confocal laser endomicroscopy (CLE) DEVICE

Confocal laser endomicroscopy (CLE) is another novel imaging tool for enabling histopathologic diagnosis in vivo during endoscopy. Specially designed confocal endoscopes have the confocal laser microscope integrated to the distal tip of the conventional endoscope. This provide images at a cellular level that have been shown to have a high sensitivity, specificity and accuracy

Also known as: Probe-based Confocal Laser Endomicroscopy (pCLE), Confocal miniprobe

Confocal Laser Endomicroscopy Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• referral for screening and/or surveillance colonoscopy and the ability to provide informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Midwest Biomedical Research Foundation: lead
• American Society for Gastrointestinal Endoscopy: collaborator

Study Sites (1)

Veterans Affairs Medical Center

Kansas City, Missouri, 64128, United States

Location

MeSH Terms

Conditions

Colonic Polyps; Adenomatous Polyps; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Amit Rastogi, MBBS

  Kansas City Veterans Affairs Medical center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sydney S Johnson, MBBS

CONTACT

816-861-4700; sydney.johnson@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investagator

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 4, 2010
• Study Start: September 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 9, 2012

Record last verified: 2012-04

Locations

US (1)