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Experience and Enhancement: Improving Colonoscopic Polyp Detection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by London North West Healthcare NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
London North West Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT00237276
First received: October 10, 2005
Last updated: September 21, 2007
Last verified: September 2007
  Purpose

The study looks at 2 hypotheses in 2 patient groups:

  1. Are more experienced endoscopists better at detecting subtle lesions (polyps) on the lining of the colon (large bowel) than less experienced endoscopists?
  2. Do existing and new techniques that can highlight lesions on the lining of the bowel improve endoscopists ability to spot them? This will be tested using video footage of endoscopies from 2 patient groups: those with a normal colon linig and those with colitis (bowel lining inflamation)

Condition Intervention
Polyps
Procedure: colonoscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Effect of Colonoscopist Experience and Addition of of Mucosal Enhancement Techniques on Detection of Colonic Polyps When Viewing Videotaped Colonoscopic Withdrawals

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The difference in adenoma detection rate on video between consultants endoscopist vs. trainee endoscopists who have performed more than 200 endoscopies vs. trainee endospopists who have performed less than 200 endoscopies

Secondary Outcome Measures:
  • For each technique:
  • differences in adenoma detection rate between endoscopist of varying abilities with and without techniques to highlight polyps. Differences in adenoma detection rate in terms of esperience.

Estimated Enrollment: 30
Study Start Date: October 2005
Detailed Description:

Colorectal cancer is the second commonest cause of cancer death. In a majority of cases it is preceeded by a precancerous lesion called an adenoma (commonly known as polyp). Patients with colitis are at specially high risk of colorectal cancer which is estimated to be 18% at 30 years of disease. Detection and removal of adenomas at colonoscopy has been shown to reduce the death rate from colorectal cancer. However, despite meticulous examination there is a "miss rate" for adenomas at colonoscopy with ranges from 6-15% in back-to-back colonoscopy studies. The nature of the polyps which as well as being pedunculated (cherry like) can be flat or depressed making them difficult to see and may also contribute 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. Endoscopist experience is assumed to improve polyp detection rates; however in one study the least experienced endoscopists found the most polyps. Techniques that highlight lesions advanced in recent years. Chromoendoscopy, spraying dye on the bowel lining, has been shown to help pick up more pre-cancerous polyp in one of three studies in normal patients and seems definitely helpful in colitis. Autofluorescence endoscopy and narrow band imaging 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. High definition endoscopy produces very clear images and may also help in polyp detection.

This study aims to collect videos of colonoscopy when the colonoscope is being removed. This is the main time when polyps are looked for. Some videos will have subtle polyps. The study will re-examine and re-video these areas using one of the techniques which may make polyps stand out better. The aim is to get videos of polyps with and without each of the techniques to highlight the lesions in both normal colon and colitis. These videos will then be shown to endoscopist of differing experience to test if their ability to spot the lesions depends on experience and to see if techniques to make lesions stand out help them see lesions more easily.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients: over 18 years of age, with clinical indication for colonoscopy who are considered by the endoscopist to be fit for the procedure
  • Endoscopists who have started colonoscopy training on a recognised training rotation. Consultants who perform colonoscopy regularly

Exclusion Criteria:

  • patients under 18 years, patients with previous colorectal surgery or known familial polyposis, patients unable to give informed consent, pregnant patients, patients for whom coloscope insertion was difficult or uncomfortable, patients whose colon is not sufficiently cleared of stool, those unwilling to participate
  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: NCT00237276

Contacts
Contact: Brian Saunders, MD, FRCP b.saunders@imperial.ac.uk
Contact: James East, MBChB, MRCP 020 8235 4033

Locations
United Kingdom
North West London Hospitals NHS Trust - St Mark's Hospital Recruiting
London, United Kingdom, HA1 3Uj
Contact: Alan Warnes, PhD       alan.warnes@nwlh.nhs.uk   
Contact: Iva Hauptmannova, MA       iva.hauptmannova@nwlh.nhs.uk   
Principal Investigator: Brian Saunders, MD, FRCP         
Sponsors and Collaborators
London North West Healthcare NHS Trust
Investigators
Principal Investigator: Brian Saunders, MD, FRCP London North West Healthcare NHS Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00237276     History of Changes
Other Study ID Numbers: 05/CL05/70
Study First Received: October 10, 2005
Last Updated: September 21, 2007
Health Authority: United Kingdom: National Health Service

Keywords provided by London North West Healthcare NHS Trust:
colonoscopy, chromoendoscopy, autoflurescence, narrow band imaging, high definition endoscopy, colorectal cancer, colitis, polyp, DALM, adenoma, video

Additional relevant MeSH terms:
Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 25, 2014