Condition category
Cancer
Date applied
05/09/2007
Date assigned
05/09/2007
Last edited
30/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
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
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 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

10/07/2007

Overall trial end date

31/12/2008

Reason abandoned

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

http://www.amc.nl/

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

Results - basic reporting

Publication summary

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

  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