Abstract

BACKGROUND:

As the acceptance of cryoablative therapies for the treatment of non-metastatic cancers continues to grow, avenues for novel cryosurgical technologies and approaches have opened. Within the field of genitourinary tumors, cryosurgical treatments of bladder cancers remain largely investigational. Current modalities employ percutaneous needles or transurethral cryoballoons or sprays, and while results have been promising, each technology is limited to specific types and stages of cancers.

OBJECTIVE:

This study evaluated a new, self-contained transurethral cryocatheter, FrostBite-BC, for its potential to treat bladder cancer.

METHODS:

Thermal characteristics and ablative capacity were assessed using calorimetry, isothermal analyses, in vitro 3-dimensional tissue engineered models (TEMs), and a pilot in vivo porcine study.

RESULTS:

Isotherm assessment revealed surface temperatures below – 20°C within 9 sec. In vitro TEMs studies demonstrated attainment of ≤– 20°C at 6.1 mm and 8.2 mm in diameter following single and double 2 min freezes, respectively. Fluorescent imaging 24 hr post-thaw revealed uniform, ablative volumes of 326.2 mm³ and 397.9 mm³ following a single or double 2 min freeze. In vivo results demonstrated the consistent generation of ablative areas. Lesion depth was found to correlate with freeze time wherein 15 sec freezes resulted in ablation confined to the sub-mucosa and ≥30 sec full thickness ablation of the bladder wall.

CONCLUSIONS:

These studies demonstrate the potential of the FrostBite-BC cryocatheter as a treatment option for bladder cancer. Although preliminary, the outcomes of these studies were encouraging, and support the continued investigation into the potential of the FrostBite-BC cryocatheter as a next generation, minimally invasive cryoablative technology.

中文翻译：

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新型细胞镜兼容冷冻导管治疗膀胱癌的评估

摘要

背景：

随着用于非转移性癌症治疗的冷冻疗法的接受度不断增长，新型冷冻外科技术和方法的途径已经打开。在泌尿生殖系统肿瘤领域，膀胱癌的冷冻外科治疗仍在很大程度上进行研究。当前的方式采用经皮穿刺针或经尿道冷冻气球或喷雾剂，虽然结果令人鼓舞，但每种技术仅限于特定类型和阶段的癌症。

目的：

这项研究评估了一种新的，自成体系的经尿道冷冻导管FrostBite-BC，它具有治疗膀胱癌的潜力。

方法：

使用量热法，等温分析，体外3维组织工程模型（TEM）和体内猪实验研究评估了热特性和烧蚀能力。

结果：

等温线评估显示9秒内表面温度低于– 20°C。体外TEM研究表明，分别冷冻一分钟和两次2分钟后，在6.1 mm和8.2 mm的直径下分别达到≤20°C。解冻后24小时的荧光成像显示，一次或两次冷冻2分钟后，烧蚀体积分别为326.2 mm ³和397.9 mm ³。体内结果证明了烧蚀区域的一致产生。发现病变深度与冻结时间相关，其中冻结15秒会导致局限于粘膜下层的消融和≥30秒的膀胱壁全层消融。

结论：

这些研究证明了FrostBite-BC冷冻导管作为膀胱癌治疗选择的潜力。尽管是初步的，但这些研究的结果令人鼓舞，并支持继续研究FrostBite-BC冷冻导管作为下一代微创冷冻凝固技术的潜力。