The Value of Virtual Chromoendoscopy With i-SCAN and Confocal Laser Endomicroscopy in the Assessement of Dysplasia on Patients With Inflammatory Bowel Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- p-CLE findings during conventional colonoscopy and I-scan colonoscopy.
Study Overview
Brief Summary
Recently, Confocal Laser Endomicroscopy (CLE) has been developed as a novel technique that actually enables in vivo microscopic analysis of the gastrointestinal tract, during ongoing endoscopy. The potential role of CLE has been explored in pathology of both upper and lower gastrointestinal tract, showing good accuracy for predicting the final histopathological diagnosis, based on immediate evaluation of tissue and vascular patterns. Because of its minute scanning area, this techology is best used in conjunction with other "red-flag" techniques to screen the mucosa for areas of interest, which can then be examined by CLE for a histological diagnosis. I-scan technology (Pentax, Tokyo, Japan) is a new image-enhanced endoscopic technique that can achieve a virtual chromoendoscopy, but until now there have been no studies to determine the role of this technology in the evaluation of activity in inflammatory bowel disease. The study protocol is based on comparing imaging findings of p-CLE in conjunction with I-scan endoscopy with activity score and histological diagnosis of inflammatory bowel disease. CLE might have an important role in IBD patients management, by assessing the inflammation, dysplasia or response to treatment.
Detailed Description
The value of I-Scan and Confocal Laser Endomicroscopy for the assessment of chronic inflammatory bowel disease
Background Colonoscopy plays an important role in the diagnosis, assessment of activity, extension and response to therapy in chronic inflammatory bowel disease (IBD). Conventional examination underestimates extent and activity of the disease compared with histology, therefore, mucosal biopsy is a critical component of endoscopic examination of these patients. Taking multiple biopsies is time consuming, carries a low but not negligible risk of secondary hemorrahage, and causes a delay in diagnosis, whilst awaiting histological analysis.
Confocal laser endomicroscopy has emerged in recent years as a novel technique that actually enables in vivo microscopic analysis during ongoing endoscopy. Endomicroscopy can be performed either with a dedicated endoscope (eCLE) or with miniprobe-based systems (pCLE) [1]. It is a contrast based technique, the most widely used agent being the intravenously administered fluorescein [2]. The probe-based endomicroscopy system consists of a flexible catheter probe representing a bundle of optical fibers linked to a micro-objective, a laser scanning unit and the control and acquisition software (Cellvizio; Mauna Kea Technology, Paris, France). The flexible confocal miniprobes were specifically designed to be passed through the working channels of standard endoscopes, biliary catheters or cholangioscopes and thus the pCLE system can be easily integrated into any endoscopy unit. The principle of the technique is based on a laser beam of defined wavelength being focused towards the targeted tissue and the recaptured signal is displayed as 'optical biopsies' in a single horizontal plane.
The potential role of CLE has been explored in pathology of both upper and lower gastrointestinal tract, showing good accuracy for predicting the final histopathological diagnosis based on immediate evaluation of tissue and vascular patterns [3]. Because of its minute scanning area, this techology is best used in conjunction with other "red-flag" techniques to screen the mucosa for areas of interest, which can then be examined by CLE for a histological diagnosis [4].
I-scan technology (Pentax, Tokyo, Japan) is a new image-enhanced endoscopic technique, consisting of three types of algorithms: surface enhancement (SE; enhancement of the structure through recognition of the edges), contrast enhancement (CE; enhancement of depressed areas and differences in structure through colored presentation of low density areas) and tone enhancement (TE; enhancement tailored to individual organs through modification of the combination of RGB components for each pixel) [5,6]. Like narrow band imaging i-scan can achieve a virtual chromoendoscopy, but until now there have been no studies to determine the role of this technology in the evaluation of activity in inflammatory bowel disease [7].
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 18 years old, male or female
- •Patients diagnosed with active ulcerative colitis (MAYO score >3) or Crohn's disease (CDAI score >150), where an indication for treatment and colonoscopy exists. Newly diagnosed as well as patients already on oral 5-ASA therapy, may be included.
- •Signed informed consent for colonoscopy and p-CLE examination
Exclusion Criteria
- •Failure to provide informed consent
- •Patients with a contraindication to colonoscopy
- •Known allergy to fluorescein
- •Pregnant or breast-feeding patients
- •Ongoing systemic immunosuppressive therapy with prednisolone, azathioprine or biological agents.
Outcomes
Primary Outcomes
p-CLE findings during conventional colonoscopy and I-scan colonoscopy.
Time Frame: 12 months
Secondary Outcomes
No secondary outcomes reported