Original article
Clinical endoscopy
Esophageal-guided biopsy with volumetric laser endomicroscopy and laser cautery marking: a pilot clinical study

https://doi.org/10.1016/j.gie.2013.11.016Get rights and content

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.)

Section snippets

OCT VLE imaging system and balloon catheter

A schematic of the VLE imaging system and balloon-centering catheter is shown in Figure 1. The imaging system obtains microscopic images using optical frequency domain imaging (OFDI), a second-generation, high-speed form of OCT technology.7 OFDI images were acquired at a rate of 40,000 axial scans (A-lines, depth-resolved reflectivity profiles) per second.6 Each cross-sectional esophageal image contained 4096 A-lines; the resultant cross-sectional frame rate was 10 per second. The power, center

Results

The cautery-marking laser power emanating from the balloon-centering catheter was approximately 280 mW for the first 10 patients. One patient was excluded because of an esophageal stricture. During these procedures, a total of 14 sets of laser cautery marks were placed, with uneven success. Of these first 10 cases, only 6 sets of laser cautery marks (43%) were clearly visualized by endoscopy. For subsequent patients, the cautery-marking laser power transmitted through the balloon-centering

Discussion

In this article, we have demonstrated a new paradigm for guided biopsy of the esophagus in which, during acquisition of a 3-dimensional microscopic esophageal dataset, the operator clicks on a target region of interest on the image and creates laser cautery marks that delineate the target in the patient. Our findings in humans show that VLE-guided biopsy, implemented using 410 mW cautery laser irradiation, is a safe technique that reliably provides endoscopically visible marks on the esophagus

Acknowledgments

The authors gratefully acknowledge the support of W. Puricelli, A. Soomro, and J. Namati. We additionally would like to thank M. Shishkov for his technical assistance with device and component fabrication. We also acknowledge NinePoint Medical for use of their VLE viewer for visualization of images at a 1:1 aspect ratio.

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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.

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