Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

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

Trial website

Contact information



Primary contact

Dr Evelien Dekker


Contact details

Academic Medical Centre (AMC)
Department of Gastroenterology and Hepatology
P.O. Box 22660
1100 DD
+31 (0)20 566 3632

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Endoscopic Tri-Modal Imaging (ETMI) for the detection and classification of early colorectal neoplasia: a multicentre randomised controlled trial


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


Secondary study design

Randomised parallel trial

Trial setting


Trial type


Patient information sheet


Colorectal neoplasia


ETMI tandem colonoscopy: high resolution endoscopy (HRE) followed by autofluorescence imaging (AFI)
Conventional colonoscopy: standard resolution colonoscopy followed by standard resolution colonoscopy

Intervention type



Drug names

Primary outcome measures

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


Overall trial end date


Reason abandoned


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment


Trial participating centre

Academic Medical Centre (AMC)
1100 DD

Sponsor information


Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Department of Hepato- and Gastroenterology
P.O. Box 22660
1100 DD

Sponsor type

Hospital/treatment centre



Funder type

Research organisation

Funder name


Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit



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

Results - basic reporting

Publication summary

1. 2009 results in
2. 2011 results in

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes