- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00253812
Adenoma Detection Rate:NBI, AFI, Chromoscopic or Standard Endoscopy
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: James East, BSc, MBChB, MRCP
- Phone Number: 0044 208 235 4025
- Email: jameseast@yahoo.com
Study Contact Backup
- Name: Brian Saunders, MD, FRCP
- Phone Number: 0044 0208423 3588
- Email: b.saunders@imperial.ac.uk
Study Locations
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Middlesex
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London, Middlesex, United Kingdom, HA1 3UJ
- Recruiting
- Norht West London Hospitals NHS Trust
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Contact:
- Alan Warnes, PhD
- Phone Number: 0044208 869 2011
- Email: alan.warnes@nwlh.nhs.uk
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Contact:
- Iva Hauptmannova, BSc, MA
- Phone Number: 020 8869 5286
- Email: iva.hauptmannova@nwlh.nhs.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with Familial adenomatous polyposis who have had ileo-rectal anastomosis and had 20 or less adenomas at previous surveillance examination
Exclusion Criteria:
- poor bowel preparation, unable or unwilling to give informed consent, under 18 years of age,those with more than 20 adenoma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary outcome measure will be the mean number of adenomas detected on the blinded video review for each endoscopy
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Secondary Outcome Measures
Outcome Measure |
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Adenoma detection rate for each of the modalities compared with each other.
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Primary endoscopist adenoma count for each modality.
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Collaborators and Investigators
Investigators
- Study Director: Brian Saunders, MD, FRCP, Nort West London Hospitals NHS Trust - St Mark's Hospital
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Genetic Diseases, Inborn
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Neoplastic Syndromes, Hereditary
- Adenomatous Polyps
- Intestinal Polyposis
- Adenoma
- Adenomatous Polyposis Coli
Other Study ID Numbers
- 05ADR-88
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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