Clinical Trial: Adenoma Detection Rate:NBI, AFI, Chromoscopic or Standard Endoscopy
Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional
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 Chromos
Brief Summary: The purpose of this study is to establish whether new techniques that may make polyps (adenomas) stand out better from the background help increase the number of polyps visible at sigmoidoscopy (telescope test to look inside large bowel) compared to looking with standard sigmoidoscopy alone.
Detailed Summary:
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 tech
Sponsor: London North West Healthcare NHS Trust
Current Primary Outcome: The primary outcome measure will be the mean number of adenomas detected on the blinded video review for each endoscopy
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Adenoma detection rate for each of the modalities compared with each other.
- Primary endoscopist adenoma count for each modality.
Original Secondary Outcome: Same as current
Information By: London North West Healthcare NHS Trust
Dates:
Date Received: November 11, 2005
Date Started: November 2005
Date Completion:
Last Updated: September 21, 2007
Last Verified: September 2007
