Esophageal-guided biopsy with volumetric laser endomicroscopy and laser cautery marking: a pilot clinical study.
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.


METHODS
A pilot feasibility study.


METHODS
Massachusetts General Hospital.


METHODS
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.


METHODS
Volumetric laser endomicroscopy.


METHODS
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.


CONCLUSIONS
This is a single-center feasibility study with a limited number of patients.


CONCLUSIONS
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. (


BACKGROUND
NCT01439633.).
Pulmonology and Critical Care Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA; Wellman Center for Photomedicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Melissa J
MJ
Suter
Wellman Center for Photomedicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Michalina J
MJ
Gora
Department of Pathology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Gregory Y
GY
Lauwers
Department of Pathology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Thomas
T
Arnason
Gastrointestinal Endoscopy Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Jenny
J
Sauk
Wellman Center for Photomedicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Kevin A
KA
Gallagher
Wellman Center for Photomedicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Lauren
L
Kava
Pulmonology and Critical Care Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Khay M
KM
Tan
Wellman Center for Photomedicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Amna R
AR
Soomro
Wellman Center for Photomedicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Timothy P
TP
Gallagher
Wellman Center for Photomedicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Joseph A
JA
Gardecki
Wellman Center for Photomedicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA; Department of Dermatology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA; Harvard-MIT Health Sciences and Technology, Cambridge, Massachusetts, USA.
Brett E
BE
Bouma
Wellman Center for Photomedicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Mireille
M
Rosenberg
Wellman Center for Photomedicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA; Gastrointestinal Endoscopy Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Norman S
NS
Nishioka
Wellman Center for Photomedicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA; Department of Pathology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA; Harvard-MIT Health Sciences and Technology, Cambridge, Massachusetts, USA.
Guillermo J
GJ
Tearney
D000368:Aged; D001471:Barrett Esophagus / Q000473:pathology* / Q000601:surgery; D004945:Esophagoscopy / Q000379:methods*; D004947:Esophagus / Q000473:pathology* / Q000601:surgery; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D061705:Image-Guided Biopsy / Q000379:methods*; D053685:Laser Therapy / Q000379:methods*; D008297:Male; D018613:Microscopy, Confocal; D008875:Middle Aged; D010865:Pilot Projects; D041623:Tomography, Optical Coherence