Endoscopic Tri-Modal Imaging (ETMI) for the detection of early neoplasia in patients with Barrett’s esophagus (BE) in tertiary referral centers; a randomized cross-over multi-center study.
- Conditions
- Barrett's esophagusAutofuorescence imagingNarrow band imaging
- Registration Number
- NL-OMON24455
- Lead Sponsor
- Academic Medical Center, Amsterdam
- Brief Summary
Curvers WL, Wong Kee Song LM, Wang K, Gostout CJ, Wallace MB, Wolfsen HC, Ragunath R, Fockens P, Bergman JJ. Endoscopic Tri-Modal Imaging (ETMI) for the Detection of Dysplastic Lesions in Barrett's Esophagus; a multi-centre feasibility study. Endosc 2006; 38 (suppl II) A34.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 84
1. Age > 18 years;
2. Prior diagnosis of BE defined as the presence of columnar lined epithelium in the tubular esophagus 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>2M>2 or C<2M>4 according to the Prague C&M classification of the endoscopic appearance of BE;
4. Written informed consent.
1. Presence of active erosive esophagitis > grade A according to the Los Angles classification of erosive esophagitis;
2. Description of an endoscopically visible suspicious lesion in the Barrett’s segment in the referring center;
3. Presence of conditions precluding histological sampling of the esophagus (e.g. esophageal varices, coagulation disorders, anticoagulant therapy);
4. At the first endoscopy: the presence of a type 0-I or type 0-III lesion or a lesion that, according to the discretion of the endoscopist, does not allow a delay in intervention for a period of 6 weeks (interval between the two cross-over endoscopies).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The number of patients and the number of lesions with early neoplasia detected with SVE and ETMI;<br>2. The number of patients with early neoplasia detected with targeted biopsies only with ETMI and SVE. <br><br>
- Secondary Outcome Measures
Name Time Method 1. The sensitivity and positive predictive value (PPV) of HRE and AFI; <br>2. The reduction of false positive findings after NBI;<br>3. Negative predictive value of the combination of HRE and AFI and the reduction in false negative findings after.