Endoscopic Tri-Modal Imaging for the detection of early neoplasia in patients with Barrett's oesophagus in tertiary referral Centres: a randomised cross-over multicentre study

ISRCTN	ISRCTN68328077
DOI	https://doi.org/10.1186/ISRCTN68328077
Protocol serial number	N/A
Sponsor	Academic Medical Centre (AMC) (The Netherlands)
Funder	Olympus Corporation (Japan)

Submission date: 30/05/2007
Registration date: 30/05/2007
Last edited: 05/11/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jacques Bergman
Scientific

Academic Medical Centre (AMC)
Department of Gastroenterology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 5663556
Email	j.j.bergman@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Randomised, active controlled, multicentre, crossover trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	ETMIC
Study objectives	Endoscopic Tri-Modal Imaging (ETMI) improves the detection of early neoplasia in Barrett's oEsophagus (BE).
Ethics approval(s)	Approval received from the Medical Ethical Commission of the Academic Medical Centre on the 18th January 2007 (ref: MEC 06/292).
Health condition(s) or problem(s) studied	Barrett's oesophagus, autofluorescence imaging, narrow band imaging
Intervention	In this study we will compare diagnostic endoscopy techniques for the detection of early neoplasia in Barrett's oesophagus. These techniques are Standard Video Endoscopy (SVE) (the current standard) and Endoscopic Tri-Modal Imaging (ETMI). Patients will undergo two consecutive endoscopies in an interval of 8 to 12 weeks. One of the two aforementioned techniques will be randomly assigned to the first procedure; the second procedure will subsequently be performed with the other technique by a second endoscopist. The primary outcome will be the number of lesions and patients with early neoplasia detected with standard video endoscopy and ETMI.
Intervention type	Other
Primary outcome measure(s)	1. The number of patients and the number of lesions with early neoplasia detected with SVE and ETMI 2. The number of patients with early neoplasia detected with targeted biopsies only with ETMI and SVE
Key secondary outcome measure(s)	1. The sensitivity and Positive Predictive Value (PPV) of High-Resolution Endoscopy (HRE) and Autofluorescence Imaging (AFI) 2. The reduction of false positive findings after Narrow Band Imaging (NBI) 3. Negative predictive value of the combination of HRE and AFI and the reduction in false negative findings after
Completion date	01/09/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	84
Key inclusion criteria	1. Aged greater than 18 years 2. Prior diagnosis of BE defined as the presence of columnar lined epithelium in the tubular oesophagus with specialised intestinal metaplasia on histological investigation 3. Prior diagnosis of high-grade dysplasia or early cancer that was endoscopically inconspicuous according to the referring physician. Review of the pathology slides is not required for inclusion 4. A minimum Barrett's length of C greater than 2M greater than 2 or C less than 2M greater than 4 according to the Prague C&M classification of the endoscopic appearance of BE 5. Written informed consent
Key exclusion criteria	1. Presence of active erosive oesophagitis greater than grade A according to the Los Angles classification of erosive oesophagitis 2. Description of an endoscopically visible suspicious lesion in the Barrett's segment in the referring centre 3. Presence of conditions precluding histological sampling of the oesophagus (e.g. oesophageal varices, coagulation disorders, anticoagulant therapy)
Date of first enrolment	01/03/2007
Date of final enrolment	01/09/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Centre (AMC)

Amsterdam
1100 DD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2007		Yes	No
Results article	results	01/10/2010		Yes	No