Adenoma Detection Rate:NBI, AFI, Chromoscopic or Standard Endoscopy
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|ClinicalTrials.gov Identifier: NCT00253812|
Recruitment Status : Unknown
Verified September 2007 by London North West Healthcare NHS Trust.
Recruitment status was: Recruiting
First Posted : November 15, 2005
Last Update Posted : September 24, 2007
|Condition or disease||Intervention/treatment||Phase|
|Familial Adenomatous Polyposis||Procedure: flexible sigmoidoscopy||Not Applicable|
Colorectal cancer is the second commonest cause of cancer death. In majority of cases it is preceeded by a precancerous lesion called an adenoma (commonly known as polyp). Detection and removal of adenomas has been shown to reduce the death rate from colorectal cancer. Despite of meticulous examination "a miss rate" for adenomas at colonoscopy ranges from 6-15% in back-to-back colonoscopy studies. The nature of the polyps, which as well as being pedunculated (cherry like) can also be flat, which makes it difficult to see and detect and may add to the"miss rate".
The factors that affect whether an endoscopist sees a polyp are not well studied. Polyp detection rates vary widely, even amongst experts. Techniques that highlight lesions advanced in recent years. Chromoendoscopy, spraying dye on the bowel lining, has been shown to help pick up more precancerous polyps in one of three studies in normal patients. Autofluorescence endoscopy (AFI) and narrow band imaging (NBI) use 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.
Patients with familial adenomatous polyposis (FAP) have many hundreds of bowel polyps due to a genetic defect and are at very high risk of colorectal cancer. Many of them have the majority of the large bowel removed with only lowest part of the large bowel, the rectum, left and joined to the small bowel. The remaining rectum can still have up to 50 polyps and is regularly surveilled with sigmoidoscopy to see if any large polyps have grown so they can be removed before they turn into cancer. Some of these polyps are small and flat.
We aim to see if using the new enhancement techniques we can detect more polyps in patients with FAP than with standard endoscopy.The patients will undergo flexible sigmoidoscopy as usual. This will then be repeated with the auto fluorescence feature of the endoscope activated, followed by a repeat with the narrow band feature activate. Then the lining of the bowel will be sprayed with blue dye (non-absorbed) and extra dye suctioned, the viewing process will be repeated the final time. This should take approx. 5 minutes. The videos from the procedures will be anonymised and randomised for viewing by another endoscopist.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Adenoma Detection Rate in Rectal Remnants of Familial Polyposis (FAP) Patients Using Standard (White Light), Auto-Fluorescence (AFI), Narrow Band Imaging (NBI) and Chromoscopic Endoscopy|
|Study Start Date :||November 2005|
- The primary outcome measure will be the mean number of adenomas detected on the blinded video review for each endoscopy
- Adenoma detection rate for each of the modalities compared with each other.
- Primary endoscopist adenoma count for each modality.
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): NCT00253812
|Contact: James East, BSc, MBChB, MRCP||0044 208 235 firstname.lastname@example.org|
|Contact: Brian Saunders, MD, FRCP||0044 0208423 email@example.com|
|Norht West London Hospitals NHS Trust||Recruiting|
|London, Middlesex, United Kingdom, HA1 3UJ|
|Contact: Alan Warnes, PhD 0044208 869 2011 firstname.lastname@example.org|
|Contact: Iva Hauptmannova, BSc, MA 020 8869 5286 email@example.com|
|Study Director:||Brian Saunders, MD, FRCP||Nort West London Hospitals NHS Trust - St Mark's Hospital|