Plain English Summary
Background and study aims
A colonoscopy is an examination where a long flexible tube (endoscope) with a light and camera on the end is inserted through your back passage. This enables the doctor or nurse to get a clear view of the bowel lining to look for polyps. These polyps are potentially dangerous because a small number of them become malignant after several years. This is why it is important that the endoscopist finds these polyps and removes them. We know from previous research that a number of polyps are being missed during a colonoscopy. There are different reasons for a polyp to be missed; they can be very small or hidden behind a fold, for example. Normally, a colonoscopy is performed with standard white light. Several new techniques have been developed to improve the quality of colonscopy. These new techniques have made it possible to better visualize the colon, which could lead to fewer polyps being missed. One of these techniques is called autofluorescence imaging (AFI), another new technique is called narrow band imaging (NBI). During AFI, the colon is being inspected with fluorescing light, while during NBI the colon is being inspected with a particular wavelength of light (mostly blue). Both of these techniques can be incorporated into a normal endoscope. This means that an endoscopist can change between any of the techniques by pressing a button on the endoscope. The aim of this study is to compare the two new techniques (AFI and NBI) with the standard technique, which is normal white light.
Who can participate?
Patients aged over 18 undergoing colonoscopy because of polyps or colorectal cancer in the past, complaints such as changes in bowel habits or rectal blood loss, or family history of colorectal cancer.
What does the study involve?
The preparation before the colonoscopy (bowel cleansing) is done as usual. The colonoscopy itself is also similar to a regular colonoscopy. In order to assess whether any of these techniques are better at detecting polyps, we need to know whether any polyps are being missed. This means that the colon needs to be inspected twice. Participants are randomly allocated into two groups; for one group the colon is inspected twice with standard white light, while the other group will have inspection with white light first and AFI/NBI during the second inspection.
What are the possible benefits and risks of participating?
Colonoscopy is a safe procedure with a very small chance of complications. Because of the double inspection, the colonoscopy is prolonged by about 15 minutes but the risk of complications is not increased.
Where is the study run from?
The study will run in multiple hospitals in the Amsterdam region. These include the Tergooi ziekenhuis Hilversum, Medical Centre Alkmaar, Lucas Andreas Amsterdam, Spaarne Ziekenhuis in Hoofddorp, Flevo Ziekenhuis in Almere and the Onze Lieve Vrouwe Gasthuis in Amsterdam. The lead centre for this study is the Academic Medical Centre in Amsterdam.
When is the study starting and how long is it expected to run for?
July 2007 to December 2008
Who is funding the study?
ZonMw, the Netherlands organisation for health research and development
Who is the main contact?
Dr Evelien Dekker
e.dekker@amc.uva.nl
Trial website
Contact information
Type
Scientific
Primary contact
Dr Evelien Dekker
ORCID ID
Contact details
Academic Medical Centre (AMC)
Department of Gastroenterology and Hepatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 3632
E.Dekker@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR1039
Study information
Scientific title
Endoscopic Tri-Modal Imaging (ETMI) for the detection and classification of early colorectal neoplasia: a multicentre randomised controlled trial
Acronym
Study hypothesis
Endoscopic Tri-Modal Imaging (ETMI) increases the detection rate of colorectal adenomas compared to conventional colonoscopy.
Ethics approval
Received from the local medical ethics committee
Study design
Multicentre randomised active-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
Colorectal neoplasia
Intervention
ETMI tandem colonoscopy: high resolution endoscopy (HRE) followed by autofluorescence imaging (AFI)
Conventional colonoscopy: standard resolution colonoscopy followed by standard resolution colonoscopy
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Number of adenomas detected by ETMI versus conventional colonoscopy
Secondary outcome measures
1. Number of adenomas detected by HRE versus conventional colonoscopy
2. Miss rate of HRE as followed by AFI (additional yield of AFI)
3. Accuracy of narrow band imaging (NBI) and AFI in discriminating non-neoplastic from neoplastic lesions (Kudo classification and colour)
Overall trial start date
10/07/2007
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients (greater than 18 years) undergoing colonoscopic surveillance because of:
1. History of adenomatous polyps
2. History of colorectal cancer (CRC)
3. Hereditary non-polyposis colorectal cancer
4. Family history of CRC/adenomas
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
234
Participant exclusion criteria
1. Poor bowel preparation
2. Familial adenomatous polyposis (FAP), attenuated FAP, MutY human homologue (MYH) associated polyposis or hyperplastic polyposis
3. History of inflammatory bowel disease
4. Presence of conditions precluding histological sampling of the colon (e.g. coagulation disorders, anticoagulant therapy)
Recruitment start date
10/07/2007
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (Netherlands)
Sponsor details
Department of Hepato- and Gastroenterology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
ZonMw
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19168154
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21419769
Publication citations
-
Results
van den Broek FJ, Fockens P, Van Eeden S, Kara MA, Hardwick JC, Reitsma JB, Dekker E, Clinical evaluation of endoscopic trimodal imaging for the detection and differentiation of colonic polyps., Clin. Gastroenterol. Hepatol., 2009, 7, 3, 288-295, doi: 10.1016/j.cgh.2008.10.025.
-
Results
Kuiper T, van den Broek FJ, Naber AH, van Soest EJ, Scholten P, Mallant-Hent RCh, van den Brande J, Jansen JM, van Oijen AH, Marsman WA, Bergman JJ, Fockens P, Dekker E, Endoscopic trimodal imaging detects colonic neoplasia as well as standard video endoscopy., Gastroenterology, 2011, 140, 7, 1887-1894, doi: 10.1053/j.gastro.2011.03.008.