Background
Biopsy surveillance protocols for the assessment of Barrett's esophagus can be subject
to sampling errors, resulting in diagnostic uncertainty. Optical coherence tomography
is a cross-sectional imaging technique that can be used to conduct volumetric laser
endomicroscopy (VLE) of the entire distal esophagus. We have developed a biopsy guidance
platform that places endoscopically visible marks at VLE-determined biopsy sites.
Objective
The objective of this study was to demonstrate in human participants the safety and
feasibility of VLE-guided biopsy in vivo.
Design
A pilot feasibility study.
Setting
Massachusetts General Hospital.
Patients
A total of 22 participants were enrolled from January 2011 to June 2012 with a prior
diagnosis of Barrett's esophagus. Twelve participants were used to optimize the laser
marking parameters and the system platform. A total of 30 target sites were selected
and marked in real-time by using the VLE-guided biopsy platform in the remaining 10
participants.
Intervention
Volumetric laser endomicroscopy.
Main Outcome Measurements
Endoscopic and VLE visibility, and accuracy of VLE diagnosis of the tissue between
the laser cautery marks.
Results
There were no adverse events of VLE and laser marking. The optimal laser marking parameters
were determined to be 2 seconds at 410 mW, with a mark separation of 6 mm. All marks
made with these parameters were visible on endoscopy and VLE. The accuracies for diagnosing
tissue in between the laser cautery marks by independent blinded readers for endoscopy
were 67% (95% confidence interval [CI], 47%-83%), for VLE intent-to-biopsy images
93% (95% CI, 78%-99%), and for corrected VLE post-marking images 100% when compared
with histopathology interpretations.
Limitations
This is a single-center feasibility study with a limited number of patients.
Conclusion
Our results demonstrate that VLE-guided biopsy of the esophagus is safe and can be
used to guide biopsy site selection based on the acquired volumetric optical coherence
tomography imaging data. (Clinical trial registration number: NCT01439633.)
Abbreviations:
BE (Barrett's esophagus), OFDI (optical frequency domain imaging), OCT (optical coherence tomography), VLE (volumetric laser endomicroscopy), IMC (intramucosal carcinoma), RJ (rotary junction)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: January 27, 2014
Accepted:
November 12,
2013
Received:
August 21,
2013
Footnotes
If you would like to chat with an author of this article, you may contact Dr Tearney at [email protected]
DISCLOSURE: Study data were collected and managed with REDCap electronic data capture tools hosted at Massachusetts General Hospital. Funding was provided by grants from the National Institutes of Health R01DK091923 (G.K.T.), R01CA103769 (G.J.T.), R21CA141884 (G.J.T.), and R00CA134920 (M.J.S.). Massachusetts General Hospital has a licensing arrangement with NinePoint Medical. M. Suter, B. Bouma, N. Nishioka, and G. Tearney have the rights to receive royalties from this licensing arrangement. G. Tearney, N. Nishioka, and B. Bouma consult for NinePoint Medical, and M. Suter, B. Bouma, and G. Tearney receive sponsored research funding from NinePoint Medical. All other authors disclosed no financial relationships relevant to this publication.
Identification
Copyright
© 2014 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.
