NBI With Magnification for Dysplasia Detection in Ulcerative Colitis
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|ClinicalTrials.gov Identifier: NCT00292175|
Recruitment Status : Unknown
Verified September 2007 by London North West Healthcare NHS Trust.
Recruitment status was: Recruiting
First Posted : February 15, 2006
Last Update Posted : September 24, 2007
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Procedure: Narrow Band Imaging Procedure: colonoscopy||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomised,Controlled Trial of Narrow Band Imaging With Magnification (NBI) Versus White Light Endoscopy for Dysplasia Detection in Ulcerative Colitis Surveillance|
|Study Start Date :||February 2006|
- Effectiveness of NBI versus Light endoscopy
- Are more precancerous lessions found in total with NBI?
- Are more advanced precancerous lesions found with NBI?
- Are more patients found with more that one precancerous lesion with NBI?
- How Many lessions are successfully completely removed via the endoscope?
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00292175
|Contact: Brian Saunders, MD, FRCP||0044208235 ext email@example.com|
|Contact: James East, BSc, MBChB, MRCP||0044208235 ext firstname.lastname@example.org|
|North West London Hospitals NHS Trust - St Mark's||Recruiting|
|London, Middlesex, United Kingdom, HA1 3UJ|
|Contact: Alan Warnes, PhD 0044208 869 ext 2011 email@example.com|
|Contact: Iva Hauptmannova, BSc MA 0044208 869 ext 5286 firstname.lastname@example.org|
|Principal Investigator: Brian Saunders, MD FRCP|
|Nottingham Univesrity Hospitals NHS Trust, Queen's Medical Centre||Recruiting|
|Nottingham, United Kingdom, NG7 2UH|
|Contact: Krish Ragunath, Dr|
|Principal Investigator: Krish Ragunath, Dr|
|Principal Investigator:||Brian Saunders, MD, FRCP||London North West Healthcare NHS Trust|