Increasing the accuracy for endoscopic detection of early Barrett neoplasia, by adding probe-based confocal laser endomicroscopy to endoscopic tri-modal imaging: A feasibility study on Endoscopic Quad-Modal Imaging (EQMI)

Conditions: (1) Barrett esophagus
(2) early esophageal neoplasia
10017990
10017991

Registration Number: NL-OMON33330

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

- Age > 18 years;
- BO with a minimal circumferential length of 2 cm;
- BO without dysplasia or with LGIN (i.e. surveillance patients) or patients with BO referred for endoscopic work-up of HGIN/early cancer;
- Signed informed consent.

Exclusion Criteria

- Prior history of surgical or endoscopic treatment of esophageal neoplasia;
- Presence of erosive oesophagitis (Los Angeles classification *B);
- Inability to obtain biopsies or to perform an endoscopic resection (e.g. due to anticoagulation, coagulation disorders, varices);
- Contraindication for fluorescein administration (e.g. allergy, pregnancy, beta-blocker use);
- Unable to provide signed informed consent.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Study Phase 1:<br /><br>(1) Correlation of the real-time NBI evaluation with histological outcome;<br /><br>(2) Correlation of the real-time pCLE evaluation with histological outcome;<br /><br>(3) Reduction of the false positive rate of WLE and AFI with NBI;<br /><br>(4) Reduction of the false positive rate of WLE and AFI with pCLE.<br /><br><br /><br>Study Phase 2:<br /><br>(1) Number of endoscopic resection specimens containing early neoplasia (i.e.<br /><br>HGIN/EC) upon histological evaluation;<br /><br>(2) Number of endoscopic resection specimens without early neoplasia upon<br /><br>histological evaluation;<br /><br>(3) Number of biopsies from areas graded as negative or indefinite upon<br /><br>endoscopy, containing early neoplasia upon histological evaluation.</p><br>

Secondary Outcome Measures