CHEST
Volume 150, Issue 2, August 2016, Pages 329-336
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Original Research: Pulmonary Procedures
A Randomized Controlled Trial of a Novel Sheath Cryoprobe for Bronchoscopic Lung Biopsy in a Porcine Model

https://doi.org/10.1016/j.chest.2016.01.018Get rights and content

Background

Transbronchial forceps biopsy (FBx) has been the preferred method for obtaining bronchoscopic lung biopsy specimens. Cryoprobe biopsy (CBx) has been shown to obtain larger and higher quality samples, but is limited by its inability to retrieve the sample through the working channel of the bronchoscope, requiring the bronchoscope to leave the airway for sample retrieval.

Objective

We evaluated a novel device using a sheath cryobiopsy (SCBx). This method allows for specimen retrieval through the working channel of the bronchoscope, with the scope remaining inside the airway.

Methods

This prospective, randomized controlled, single-blinded porcine study compared a 1.1-mm SCBx probe, a 1.9-mm CBx probe, and 2.0-mm FBx forceps. Assessment of histologic accessibility, sample quantity and quality, number of attempts to acquire and retrieve samples, cryoprobe activation time, fluoroscopy activation time, technical feasibility, and complications were compared.

Results

Samples adequate for standard pathologic processing were retrieved with 82.1% of the SCBx specimens, 82.9%% of the CBx specimens, and 30% of the FBx specimens. The histologic accessibility of both SCBx (P = .0002) and CBx (P = .0003) was superior to FBx. Procedure time for FBx was faster than for both SCBx and CBx, but SCBx was significantly faster than CBx (P < .0001). Fluoroscopy time was lower for both SCBx and CBx compared with FBx. There were no significant bleeding events.

Conclusions

SCBx is a feasible technique providing a higher quality lung biopsy specimen compared with FBx and can successfully be retrieved through the working channel. Human studies are needed to further assess this technique with additional safety data.

Section snippets

Materials and Methods

The present trial included a prospective, randomized, controlled, single-blinded animal study comparing three different biopsy methods (technology and technique) in lung tissue (Fig 1). The aim of the study was to evaluate the feasibility, quality, and safety of biopsy specimens obtained by using a new 1.1-mm SCBx and to compare the results with those acquired by using a 1.9-mm CBx and 2.0-mm FBx.

The study hypothesis was that the use of the new SCBx would have histopathologic accessibility

Results

Three animals were used with a mean weight of 53.2 ± 4.3 kg. In total, 44 attempts were necessary to obtain 39 (88.6%) specimens using SCBx, 53 attempts to obtain 38 (71.7%) specimens using CBx, and 40 attempts (100%) using FBx. Overall, 17.9% of the SCBx specimens, 17.14% of the CBx specimens, and 70% of the FBx specimens were too small and had to be processed as cell blocks. All other specimens were processed as paraffin blocks and stained with hematoxylin and eosin for evaluation. A simple

Discussion

Currently, the two main options for retrieving pathologic lung samples are surgical lung biopsy and bronchoscopic FBx. Due to the more invasive nature and higher cost of surgical biopsies, a bronchoscopic approach may be preferred. However, the major limitations of FBx are small biopsy specimen size and poor cellular architecture.1, 2 CBx has been shown to obtain larger biopsy samples compared with FBx.11, 12 A new technique using a novel, smaller probe with a retractable sheath (SCBx) was

Conclusions

A novel sheath CBx allowed the bronchoscope to remain within the airway during the entire procedure. SCBx was a safe technique in this animal model, and it provided a larger biopsy specimen compared with FBx, with a similar safety and histologic profile comparable to standard CBx. Human studies are warranted.

Acknowledgments

Author contributions: L. B. Y. is designated as the guarantor, taking responsibility for the integrity of the manuscript from inception to publication. All authors contributed significantly to the study design, data acquisition, analysis, writing of the manuscript, and manuscript review.

Financial/nonfinancial disclosures: None declared.

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    FUNDING/SUPPORT: The authors have reported to CHEST that no funding was received for this study.

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