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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.

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24455
Enrollment
84
Registered
2007-03-30
Start date
2007-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's esophagus Autofuorescence imaging Narrow band imaging

Interventions

In this study we will compare diagnostic endoscopy techniques for the detection of early enoplasia in Barrett's esophagus. These techniques are standard video endoscopy (the current standard) and Endo

Sponsors

Academic Medical Center, Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 C4 according to the Prague C&M classification of the endoscopic appearance of BE; 4. Written informed consent.

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
1. The sensitivity and positive predictive value (PPV) of HRE and AFI; 2. The reduction of false positive findings after NBI; 3. Negative predictive value of the combination of HRE and AFI and the reduction in false negative findings after.

Contacts

Public ContactJ.J.G.H.M. Bergman

Academic Medical Center Bldg. C2-210, Meibergdreef

j.j.bergman@amc.uva.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)