Hwang Joo Ha, Wang Yak-Nam, Warren Cinderella, Upton Melissa P, Starr Frank, Zhou Yufeng, Mitchell Stuart B
Department of Medicine, Division of Gastroenterology, University of Washington, Seattle, WA, USA.
Ultrasound Med Biol. 2009 Jun;35(6):967-75. doi: 10.1016/j.ultrasmedbio.2008.12.006. Epub 2009 Feb 8.
Extracorporeal high-intensity focused ultrasound (HIFU) can be used to ablate tissue noninvasively by delivering focused ultrasound energy from an external source. HIFU for clinical treatment of pancreatic cancer has been reported; however, systematic evaluation of the safety and efficacy of pancreatic ablation with HIFU has not been performed. The objectives of this in vivo study are as follows: (1) assess the safety and feasibility of targeting and ablating pancreatic tissue using the FEP-BY02 HIFU system (Yuande Bio-Medical Engineering, Beijing, China); (2) evaluate a method for estimating in situ acoustic treatment energy in an in vivo setting; and (3) identify the optimal treatment parameters that result in safe and effective ablation of the pancreas. The pancreata of 12 common swine were treated in vivo. Prior to therapy, blood was drawn for laboratory analysis. Animals were then treated with extracorporeal HIFU at three different acoustic treatment energies (750, 1000 and 1250 J). Endoscopy was performed prior to and immediately following HIFU therapy to assess for gastric injury. Blood was drawn after completion of the treatment and on days 2 and 7 following treatment to assess for biochemical evidence of pancreatitis. Animals were then euthanized 7 d following treatment and a necropsy was performed to assess for unintended injury and to obtain pancreatic tissue for histology to assess efficacy of HIFU ablation. Histologic scoring of pancreatic tissue changes was performed by a pathologist blinded to the treatment energy delivered. The degree of ablation identified on histology correlated with the treatment energy. No collateral tissue damage was seen at treatment energies of 750 and 1000 J. At 1250 J, thermal injury to the abdominal muscles and gastric ulcers were observed. There were no premature deaths, serious illnesses, skin burns or evidence of pancreatitis on biochemical analysis. HIFU treatment of the pancreas is feasible, safe and can be used to ablate tissue noninvasively. A clinical trial in humans examining the use of extracorporeal HIFU for palliation of pain related to pancreatic cancer is planned.
体外高强度聚焦超声（HIFU）可通过从外部源传递聚焦超声能量来无创地消融组织。已有关于HIFU用于胰腺癌临床治疗的报道；然而，尚未对HIFU胰腺消融的安全性和有效性进行系统评估。本体内研究的目的如下：（1）评估使用FEP-BY02 HIFU系统（中国北京源德生物医学工程公司）靶向和消融胰腺组织的安全性和可行性；（2）评估一种在体内环境中估计原位声学治疗能量的方法；（3）确定导致胰腺安全有效消融的最佳治疗参数。对12只普通猪的胰腺进行了体内治疗。治疗前，采集血液进行实验室分析。然后，动物接受三种不同声学治疗能量（750、1000和1250焦耳）的体外HIFU治疗。在HIFU治疗前和治疗后立即进行内镜检查，以评估胃损伤情况。治疗完成后以及治疗后第2天和第7天采集血液，以评估胰腺炎的生化证据。然后在治疗后7天对动物实施安乐死，并进行尸检，以评估意外损伤情况，并获取胰腺组织进行组织学检查，以评估HIFU消融的疗效。由对所传递的治疗能量不知情的病理学家对胰腺组织变化进行组织学评分。组织学上确定的消融程度与治疗能量相关。在750和1000焦耳的治疗能量下未观察到附带组织损伤。在1250焦耳时，观察到腹部肌肉热损伤和胃溃疡。生化分析未发现过早死亡、严重疾病、皮肤烧伤或胰腺炎证据。HIFU治疗胰腺是可行、安全的，可用于无创地消融组织。计划开展一项针对人类的临床试验，研究体外HIFU用于缓解胰腺癌相关疼痛的情况。
