No registrations found.
ID
Source
Brief title
Health condition
Barrett oesophagus
dysplasia
neoplasia
advanced imaging
endoscopy
Barrett slokdarm
dysplasie
slokdarmkanker
geavanceerde detectie
endoscopie
Sponsors and support
Intervention
Outcome measures
Primary outcome
Phase 1 will be used to develop a tissue recognition algorithm by correlating the measured fluorescence spectra to the histology of the corresponding tissue.
In phase 2 the WavSTAT optical biopsy will be validated and assessed for the following outcome parameters:
1. Sensitivity and specificity of WavSTAT for the detection of early Barrett neoplasia (HGIN/EC);
2. Additional value of WavSTAT to standard inspection with WLE, compared to inspection with WLE alone for the detection of early Barrett neoplasia (HGIN/EC).
Secondary outcome
N/A
Background summary
Aims:
1. To investigate the WavSTAT optical biopsy system by collecting fluorescence spectra of non-dysplastic and dysplastic Barrett mucosa and correlate these to the histology. The integrated optical/physical biopsy forceps will ensure spot-on correlation. The results of this study will be used to develop a differentiating, tissue recognition algorithm;
2. In a second validation study, the algorithm is integrated in the system and patients with a Barrett oesophagus will be investigated by standard white light endoscopy and with the WavSTAT optical biopsy system to assess the additional value of this differentiation tool for the detection of early neoplasia in BO.
Study objective
We hypothesize that the WavSTAT optical biopsy system may improve the endoscopists ability to detect and distinguish suspicious lesions in the Barrett oesophagus, while reducing the need for extensive biopsy protocols during surveillance endoscopies.
Study design
Phase 1 start: May 1st 2011;
Phase 1 stop: Sept 1st 2011.
Phase 2 start: Jan 1st 2012;
Phase 2 stop: Sept 1st 2012.
Intervention
Phase 1: Development of algorithm for the WavSTAT system in 20 patients;
Phase 2: Validation of the WavSTAT system in 150 patients.
David Boerwinkel
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5664571
d.f.boerwinkel@amc.uva.nl
David Boerwinkel
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5664571
d.f.boerwinkel@amc.uva.nl
Inclusion criteria
1. Age > 18 – 80 years;
2. BO with a minimal circumferential length of 2 cm;
3. BO without dysplasia (NDBO) and patients with BO referred for endoscopic work-up of HGIN or EC;
4. Signed informed consent.
Exclusion criteria
1. Prior history of surgical or endoscopic treatment for oesophageal neoplasia;
2. Presence of erosive oesophagitis (Los Angeles classification ≥B);
3. Inability to obtain biopsies (e.g. due to anticoagulation, coagulation disorders, varices);
4. Unable to provide signed informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2721 |
| NTR-old | NTR2859 |
| CCMO | NL36255.018.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |