Adenoma Detection Rate:NBI, AFI, Chromoscopic or Standard Endoscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by North West London Hospitals NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
North West London Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00253812
First received: November 11, 2005
Last updated: September 21, 2007
Last verified: September 2007
  Purpose

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.


Condition Intervention
Familial Adenomatous Polyposis
Procedure: flexible sigmoidoscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by North West London Hospitals NHS Trust:

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.

Estimated Enrollment: 60
Study Start Date: November 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00253812

Contacts
Contact: James East, BSc, MBChB, MRCP 0044 208 235 4025 jameseast@yahoo.com
Contact: Brian Saunders, MD, FRCP 0044 0208423 3588 b.saunders@imperial.ac.uk

Locations
United Kingdom
Norht West London Hospitals NHS Trust Recruiting
London, Middlesex, United Kingdom, HA1 3UJ
Contact: Alan Warnes, PhD    0044208 869 2011    alan.warnes@nwlh.nhs.uk   
Contact: Iva Hauptmannova, BSc, MA    020 8869 5286    iva.hauptmannova@nwlh.nhs.uk   
Sponsors and Collaborators
North West London Hospitals NHS Trust
Investigators
Study Director: Brian Saunders, MD, FRCP Nort West London Hospitals NHS Trust - St Mark's Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00253812     History of Changes
Other Study ID Numbers: 05ADR-88
Study First Received: November 11, 2005
Last Updated: September 21, 2007
Health Authority: United Kingdom: National Health Service

Keywords provided by North West London Hospitals NHS Trust:
colonoscopy, sigmoidoscopy, chromoendoscopy, autofluorescence, narrow band imaging, colorectal cancer, polyp, adenoma,rectal remnant, FAP

Additional relevant MeSH terms:
Adenoma
Adenomatous Polyposis Coli
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenomatous Polyps
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Neoplasms
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Intestinal Polyposis
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on August 20, 2014