PolypsNCT00237276
Experience and Enhancement: Improving Colonoscopic Polyp Detection
A study testing colonoscopy in people with Polyps, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polyps
- What is being tested?
- colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2005to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brian Saunders, MD, FRCP contact
James East, MBChB, MRCP contact
United Kingdom1 site, 1 recruiting
- Recruiting
North West London Hospitals NHS Trust - St Mark's Hospital
London, HA1 3Uj
Alan Warnes, PhD, alan.warnes@nwlh.nhs.uk
Iva Hauptmannova, MA, iva.hauptmannova@nwlh.nhs.uk
About this study
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
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)
Read the 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.
- Conditions
- Polyps
- Being tested
- colonoscopy
- Keywords
- colonoscopy, chromoendoscopy, autoflurescence, narrow band imaging, high definition endoscopy, colorectal cancer, colitis, polyp, DALM, adenoma, video
- Medical subject headings
- Polyps, Colorectal Neoplasms, Colitis, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (2)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- Brian Saunders, MD, FRCP, Principal investigator, London North West Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237276
- Sponsor's protocol ID
- 05/CL05/70
- Status last verified
- Sep 2007
- First submitted
- 10 Oct 2005
- Last updated
- 24 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00237276
- Acronym / sponsor ID
- 05/CL05/70
- Conditions
- Polyps
- Keywords
- colonoscopy, chromoendoscopy, autoflurescence, narrow band imaging, high definition endoscopy, colorectal cancer, colitis, polyp, DALM, adenoma, video
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- Oct 2005
- First posted
- 12 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colonoscopy | Procedure or surgery | – |
Primary outcome
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
2 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Saunders, MD, FRCP contact
James East, MBChB, MRCP contact
Brian Saunders, MD, FRCP principal investigator
London North West Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing colonoscopy in people with Polyps, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian Saunders, MD, FRCP (b.saunders@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2007.