Adenoma Detection Rate:NBI, AFI, Chromoscopic or Standard Endoscopy
Primary Purpose
Familial Adenomatous Polyposis
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
flexible sigmoidoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Familial Adenomatous Polyposis focused on measuring colonoscopy, sigmoidoscopy, chromoendoscopy, autofluorescence, narrow band imaging, colorectal cancer, polyp, adenoma,rectal remnant, FAP
Eligibility Criteria
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
Sites / Locations
- Norht West London Hospitals NHS TrustRecruiting
Outcomes
Primary Outcome Measures
The primary outcome measure will be the mean number of adenomas detected on the blinded video review for each endoscopy
Secondary Outcome Measures
Adenoma detection rate for each of the modalities compared with each other.
Primary endoscopist adenoma count for each modality.
Full Information
NCT ID
NCT00253812
First Posted
November 11, 2005
Last Updated
September 21, 2007
Sponsor
London North West Healthcare NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT00253812
Brief Title
Adenoma Detection Rate:NBI, AFI, Chromoscopic or Standard Endoscopy
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 Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
London North West Healthcare NHS Trust
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Adenomatous Polyposis
Keywords
colonoscopy, sigmoidoscopy, chromoendoscopy, autofluorescence, narrow band imaging, colorectal cancer, polyp, adenoma,rectal remnant, FAP
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
flexible sigmoidoscopy
Primary Outcome Measure Information:
Title
The primary outcome measure will be the mean number of adenomas detected on the blinded video review for each endoscopy
Secondary Outcome Measure Information:
Title
Adenoma detection rate for each of the modalities compared with each other.
Title
Primary endoscopist adenoma count for each modality.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James East, BSc, MBChB, MRCP
Phone
0044 208 235 4025
Email
jameseast@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Saunders, MD, FRCP
Phone
0044 0208423 3588
Email
b.saunders@imperial.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Saunders, MD, FRCP
Organizational Affiliation
Nort West London Hospitals NHS Trust - St Mark's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Norht West London Hospitals NHS Trust
City
London
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Warnes, PhD
Phone
0044208 869 2011
Email
alan.warnes@nwlh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Iva Hauptmannova, BSc, MA
Phone
020 8869 5286
Email
iva.hauptmannova@nwlh.nhs.uk
12. IPD Sharing Statement
Learn more about this trial
Adenoma Detection Rate:NBI, AFI, Chromoscopic or Standard Endoscopy
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