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Experience and Enhancement: Improving Colonoscopic Polyp Detection

Primary Purpose

Polyps

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
colonoscopy
Sponsored by
London North West Healthcare NHS Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Polyps focused on measuring colonoscopy, chromoendoscopy, autoflurescence, narrow band imaging, high definition endoscopy, colorectal cancer, colitis, polyp, DALM, adenoma, video

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • North West London Hospitals NHS Trust - St Mark's HospitalRecruiting

Outcomes

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.

Full Information

First Posted
October 10, 2005
Last Updated
September 21, 2007
Sponsor
London North West Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00237276
Brief Title
Experience and Enhancement: Improving Colonoscopic Polyp Detection
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 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 study looks at 2 hypotheses in 2 patient groups: Are more experienced endoscopists better at detecting subtle lesions (polyps) on the lining of the colon (large bowel) than less experienced endoscopists? 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyps
Keywords
colonoscopy, chromoendoscopy, autoflurescence, narrow band imaging, high definition endoscopy, colorectal cancer, colitis, polyp, DALM, adenoma, video

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
colonoscopy
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
For each technique:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Saunders, MD, FRCP
Email
b.saunders@imperial.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
James East, MBChB, MRCP
Phone
020 8235 4033
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Saunders, MD, FRCP
Organizational Affiliation
London North West Healthcare NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
North West London Hospitals NHS Trust - St Mark's Hospital
City
London
ZIP/Postal Code
HA1 3Uj
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Warnes, PhD
Email
alan.warnes@nwlh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Iva Hauptmannova, MA
Email
iva.hauptmannova@nwlh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Brian Saunders, MD, FRCP

12. IPD Sharing Statement

Learn more about this trial

Experience and Enhancement: Improving Colonoscopic Polyp Detection

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