Dunkin B J, Martinez J, Bejarano P A, Smith C D, Chang K, Livingstone A S, Melvin W S
University of Miami School of Medicine, Miami, FL 33136, USA.
Surg Endosc. 2006 Jan;20(1):125-30. doi: 10.1007/s00464-005-8279-9. Epub 2005 Dec 7.
The goal of this study was to determine the optimal treatment parameters for the ablation of human esophageal epithelium using a balloon-based bipolar radiofrequency (RF) energy electrode.
Immediately prior to esophagectomy, subjects underwent esophagoscopy and ablation of two separate, 3-cm long, circumferential segments of non-tumor-bearing esophageal epithelium using a balloon-based bipolar RF energy electrode (BARRX Medical, Inc., Sunnyvale, CA, USA). Subjects were randomized to one of three energy density groups: 8, 10, or 12 J/cm2. RF energy was applied one time (1x) proximally and two times (2x) distally. Following resection, sections from each ablation zone were evaluated using H&E and diaphorase. Histological endpoints were complete epithelial ablation (yes/no), maximum ablation depth, and residual ablation thickness after tissue slough. Outcomes were compared according to energy density group and 1x vs 2x treatment.
Thirteen male subjects (age, 49-85 years) with esophageal adenocarcinoma underwent the ablation procedure followed by total esophagectomy. Complete epithelial removal occurred in the following zones: 10 J/cm2 (2x) and 12 J/cm2 (1x and 2x). The maximum depth of injury was the muscularis mucosae: 10 and 12 J/cm2 (both 2x). A second treatment (2x) did not significantly increase the depth of injury. Maximum thickness of residual ablation after tissue slough was only 35 microm.
Complete removal of the esophageal epithelium without injury to the submucosa or muscularis propria is possible using this balloon-based RF electrode at 10 J/cm2 (2x) or 12 J/cm2 (1x or 2x). A second application (2x) does not significantly increase ablation depth. These data have been used to select the appropriate settings for treating intestinal metaplasia in trials currently under way.
本研究的目的是确定使用基于球囊的双极射频（RF）能量电极消融人食管上皮的最佳治疗参数。
在食管切除术即将开始前，受试者接受食管镜检查，并使用基于球囊的双极RF能量电极（美国加利福尼亚州森尼韦尔市BARRX Medical公司）对两段独立的、长3厘米的无肿瘤食管上皮环周段进行消融。受试者被随机分为三个能量密度组之一：8、10或12焦耳/平方厘米。RF能量在近端施加一次（1x），在远端施加两次（2x）。切除后，使用苏木精-伊红（H&E）染色和黄递酶对每个消融区的切片进行评估。组织学终点为上皮完全消融（是/否）、最大消融深度以及组织脱落后的残余消融厚度。根据能量密度组以及1x与2x治疗比较结果。
13名患有食管腺癌的男性受试者（年龄49 - 85岁）接受了消融手术，随后进行了全食管切除术。在以下区域实现了上皮的完全去除：10焦耳/平方厘米（2x）和12焦耳/平方厘米（1x和2x）。最大损伤深度为黏膜肌层：10和12焦耳/平方厘米（均为2x）。第二次治疗（2x）并未显著增加损伤深度。组织脱落后的残余消融最大厚度仅为35微米。
使用这种基于球囊的RF电极，在10焦耳/平方厘米（2x）或12焦耳/平方厘米（1x或2x）时，可以完全去除食管上皮而不损伤黏膜下层或固有肌层。第二次应用（2x）并未显著增加消融深度。这些数据已用于在目前正在进行的试验中选择治疗肠化生的合适设置。
