The Assessment of a Novel Endoscopic Ultrasound-Compatible Cryocatheter to Ablate Pancreatic Cancer

Pancreatic ductal adenocarcinoma (PDAC) is a highly lethal disease that may be treated utilizing thermal therapies. Cryoablation is an effective, minimally invasive therapy that has been utilized for the treatment of various cancers, offering patients a quicker recovery and reduced side effects. Cry...

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Main Authors: John M. Baust, Anthony Robilotto, Isaac Raijman, Kimberly L. Santucci, Robert G. Van Buskirk, John G. Baust, Kristi K. Snyder
Format: Article
Language:English
Published: MDPI AG 2024-02-01
Series:Biomedicines
Subjects:
Online Access:https://www.mdpi.com/2227-9059/12/3/507
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author John M. Baust
Anthony Robilotto
Isaac Raijman
Kimberly L. Santucci
Robert G. Van Buskirk
John G. Baust
Kristi K. Snyder
author_facet John M. Baust
Anthony Robilotto
Isaac Raijman
Kimberly L. Santucci
Robert G. Van Buskirk
John G. Baust
Kristi K. Snyder
author_sort John M. Baust
collection DOAJ
description Pancreatic ductal adenocarcinoma (PDAC) is a highly lethal disease that may be treated utilizing thermal therapies. Cryoablation is an effective, minimally invasive therapy that has been utilized for the treatment of various cancers, offering patients a quicker recovery and reduced side effects. Cryoablation has been utilized on a limited basis for the treatment of PDAC. With the recent reports on the success of cryoablation, there is a growing interest in the use of cryoablation as a standalone, minimally invasive procedure to treat PDAC. While offering a promising path, the application of cryoablation to PDAC is limited by current technologies. As such, there is a need for the development of new devices to support advanced treatment strategies for PDAC. To this end, this study investigated the performance of a new endoscopic ultrasound-compatible cryoablation catheter technology, <i>FrostBite</i>. We hypothesized that <i>FrostBite</i> would enable the rapid, effective, minimally invasive delivery of ultra-cold temperatures to target tissues, resulting in effective ablation via an endoscopic approach. Thermal properties and ablative efficacy were evaluated using a heat-loaded gel model, tissue-engineered models (TEMs), and an initial in vivo porcine study. Freeze protocols evaluated included single and repeat 3 and 5 min applications. Isotherm assessment revealed the generation of a 2.2 cm diameter frozen mass with the −20 °C isotherm reaching a diameter of 1.5 cm following a single 5 min freeze. TEM studies revealed the achievement of temperatures ≤ −20 °C at a diameter of 1.9 cm after a 5 min freeze. Fluorescent imaging conducted 24 h post-thaw demonstrated a uniformly shaped ellipsoidal ablative zone with a midline diameter of 2.5 cm, resulting in a total ablative volume of 6.9 cm<sup>3</sup> after a single 5 min freeze. In vivo findings consistently demonstrated the generation of ablative areas measuring 2.03 cm × 3.2 cm. These studies demonstrate the potential of the <i>FrostBite</i> cryocatheter as an endoscopic ultrasound-based treatment option. The data suggest that <i>FrostBite</i> may provide for the rapid, effective, controllable freezing of cancerous pancreatic and liver tissues. This ablative power also offers the potential of improved safety margins via the minimally invasive nature of an endoscopic ultrasound-based approach or natural orifice transluminal endoscopic surgery (NOTES)-based approach. The results of this pre-clinical feasibility study show promise, affirming the need for further investigation into the potential of the <i>FrostBite</i> cryocatheter as an advanced, minimally invasive cryoablative technology.
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spelling doaj.art-4bd51d1d3e31469c910417e694963c5f2024-03-27T13:22:36ZengMDPI AGBiomedicines2227-90592024-02-0112350710.3390/biomedicines12030507The Assessment of a Novel Endoscopic Ultrasound-Compatible Cryocatheter to Ablate Pancreatic CancerJohn M. Baust0Anthony Robilotto1Isaac Raijman2Kimberly L. Santucci3Robert G. Van Buskirk4John G. Baust5Kristi K. Snyder6CPSI Biotech, Owego, NY 13827, USACPSI Biotech, Owego, NY 13827, USADepartment of Medicine-Gastroenterology, Baylor College of Medicine, Houston, TX 77030, USACPSI Biotech, Owego, NY 13827, USACPSI Biotech, Owego, NY 13827, USACenter for Translational Stem Cell and Tissue Engineering, Binghamton University, Binghamton, NY 13902, USACPSI Biotech, Owego, NY 13827, USAPancreatic ductal adenocarcinoma (PDAC) is a highly lethal disease that may be treated utilizing thermal therapies. Cryoablation is an effective, minimally invasive therapy that has been utilized for the treatment of various cancers, offering patients a quicker recovery and reduced side effects. Cryoablation has been utilized on a limited basis for the treatment of PDAC. With the recent reports on the success of cryoablation, there is a growing interest in the use of cryoablation as a standalone, minimally invasive procedure to treat PDAC. While offering a promising path, the application of cryoablation to PDAC is limited by current technologies. As such, there is a need for the development of new devices to support advanced treatment strategies for PDAC. To this end, this study investigated the performance of a new endoscopic ultrasound-compatible cryoablation catheter technology, <i>FrostBite</i>. We hypothesized that <i>FrostBite</i> would enable the rapid, effective, minimally invasive delivery of ultra-cold temperatures to target tissues, resulting in effective ablation via an endoscopic approach. Thermal properties and ablative efficacy were evaluated using a heat-loaded gel model, tissue-engineered models (TEMs), and an initial in vivo porcine study. Freeze protocols evaluated included single and repeat 3 and 5 min applications. Isotherm assessment revealed the generation of a 2.2 cm diameter frozen mass with the −20 °C isotherm reaching a diameter of 1.5 cm following a single 5 min freeze. TEM studies revealed the achievement of temperatures ≤ −20 °C at a diameter of 1.9 cm after a 5 min freeze. Fluorescent imaging conducted 24 h post-thaw demonstrated a uniformly shaped ellipsoidal ablative zone with a midline diameter of 2.5 cm, resulting in a total ablative volume of 6.9 cm<sup>3</sup> after a single 5 min freeze. In vivo findings consistently demonstrated the generation of ablative areas measuring 2.03 cm × 3.2 cm. These studies demonstrate the potential of the <i>FrostBite</i> cryocatheter as an endoscopic ultrasound-based treatment option. The data suggest that <i>FrostBite</i> may provide for the rapid, effective, controllable freezing of cancerous pancreatic and liver tissues. This ablative power also offers the potential of improved safety margins via the minimally invasive nature of an endoscopic ultrasound-based approach or natural orifice transluminal endoscopic surgery (NOTES)-based approach. The results of this pre-clinical feasibility study show promise, affirming the need for further investigation into the potential of the <i>FrostBite</i> cryocatheter as an advanced, minimally invasive cryoablative technology.https://www.mdpi.com/2227-9059/12/3/507cryoablation<i>FrostBite</i>pressurized sub-cooled nitrogentissue engineered modelsporcine modelpancreatic cancer
spellingShingle John M. Baust
Anthony Robilotto
Isaac Raijman
Kimberly L. Santucci
Robert G. Van Buskirk
John G. Baust
Kristi K. Snyder
The Assessment of a Novel Endoscopic Ultrasound-Compatible Cryocatheter to Ablate Pancreatic Cancer
Biomedicines
cryoablation
<i>FrostBite</i>
pressurized sub-cooled nitrogen
tissue engineered models
porcine model
pancreatic cancer
title The Assessment of a Novel Endoscopic Ultrasound-Compatible Cryocatheter to Ablate Pancreatic Cancer
title_full The Assessment of a Novel Endoscopic Ultrasound-Compatible Cryocatheter to Ablate Pancreatic Cancer
title_fullStr The Assessment of a Novel Endoscopic Ultrasound-Compatible Cryocatheter to Ablate Pancreatic Cancer
title_full_unstemmed The Assessment of a Novel Endoscopic Ultrasound-Compatible Cryocatheter to Ablate Pancreatic Cancer
title_short The Assessment of a Novel Endoscopic Ultrasound-Compatible Cryocatheter to Ablate Pancreatic Cancer
title_sort assessment of a novel endoscopic ultrasound compatible cryocatheter to ablate pancreatic cancer
topic cryoablation
<i>FrostBite</i>
pressurized sub-cooled nitrogen
tissue engineered models
porcine model
pancreatic cancer
url https://www.mdpi.com/2227-9059/12/3/507
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