Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352404
Status:
COMPLETED
Last Update Posted:
2006-07-14
First Post:
2006-07-13
Brief Title:
Chromoscopic Guided Endomicroscpy to Diagnose Colitis Associated Dysplasia
Sponsor:
Johannes Gutenberg University Mainz
Organization:
Johannes Gutenberg University Mainz
Study Overview
Official Title:
Diagnosis of Intraepithelial Neoplasia in Patients With Long Standing Ulcerative Colitis With Chromoscopic Guided Endomicroscopy
Status:
COMPLETED
Status Verified Date:
2003-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Timely diagnosis of intraepithelial neoplasias premalignant conditionis 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
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
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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None