Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292175
Status:
UNKNOWN
Last Update Posted:
2007-09-24
First Post:
2006-02-14
Brief Title:
NBI With Magnification for Dysplasia Detection in Ulcerative Colitis
Sponsor:
London North West Healthcare NHS Trust
Organization:
London North West Healthcare NHS Trust
Study Overview
Official Title:
RandomisedControlled Trial of Narrow Band Imaging With Magnification NBI Versus White Light Endoscopy for Dysplasia Detection in Ulcerative Colitis Surveillance
Status:
UNKNOWN
Status Verified Date:
2007-09
Last Known Status:
RECRUITING
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:
The purpose of the study is to determine whether a new colonoscopic viewing technique called narrow band imaging NBI helps doctors detect more patients with at leat one pre-cancerous area dysplasia associated lession or mass MALMs than conventional colonoscopy using white light alone
Detailed Description:
Colorectal cancer is the second commonest cause of cancer death Patients with colitis have a substantially increased risk of death from colorectal cancer which increases with lenght of time the patient has had colitis This can be as high as a 30 chance of colorectal cancer after 30 years of colitis Colonoscopic surveillance of colitis patients has been shown to reduce the risk of colorectal cancer and allow detection at an earlier stage but even with meticulous examination some precancerous lesions or cancers are missed
Precancerous lesions in colitis are difficult to see and endoscopist have used spraying dye on the lining of the bowel chromoendoscopy successfully to improve detection of abnormal areas however this is time consuming and requires extra time and equipment and despite the benefits seen in multiple studies is not widely used in routine clinical practice in the UK
Narrow band imaging NBI is a technique that relies on light filters to improve contrast for the smallest blood vessels in the bowel lining which shows up precancerous areas as they have a richer vascular network It is sometimes described as digital chromoendoscopy as the images produced are similar to chromoendoscopy but it is much simpler and quicker to use With magnification it allows assessment of the fine mucosal surface pattern pit pattern of lesion which allows and assessment of their likelihood of being precancerous Autofluorescence endoscopy uses short wavelength light and light filters to produce a false colour image of the bowel lining where polyps stand out These techniques have been used with some success in the oesophagus and stomach but little work is available for the colon
We aim to see if NBI with magnification is better that standard colonoscopy for detecting precancerous areas This is likely as it produces images similar to chromoendoscopy which is already shown to help If a potentially precancerous area is found we will use other types of endoscopy particularly NBI autofluorescence to see if these techniques are helpful for discriminating between pre-cancerous and non pre-cancerous areas
Precancerous lesions in colitis are difficult to see and endoscopist have used spraying dye on the lining of the bowel chromoendoscopy successfully to improve detection of abnormal areas however this is time consuming and requires extra time and equipment and despite the benefits seen in multiple studies is not widely used in routine clinical practice in the UK
Narrow band imaging NBI is a technique that relies on light filters to improve contrast for the smallest blood vessels in the bowel lining which shows up precancerous areas as they have a richer vascular network It is sometimes described as digital chromoendoscopy as the images produced are similar to chromoendoscopy but it is much simpler and quicker to use With magnification it allows assessment of the fine mucosal surface pattern pit pattern of lesion which allows and assessment of their likelihood of being precancerous Autofluorescence endoscopy uses short wavelength light and light filters to produce a false colour image of the bowel lining where polyps stand out These techniques have been used with some success in the oesophagus and stomach but little work is available for the colon
We aim to see if NBI with magnification is better that standard colonoscopy for detecting precancerous areas This is likely as it produces images similar to chromoendoscopy which is already shown to help If a potentially precancerous area is found we will use other types of endoscopy particularly NBI autofluorescence to see if these techniques are helpful for discriminating between pre-cancerous and non pre-cancerous areas
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