Sharma Virender K, Wang Kenneth K, Overholt Bergein F, Lightdale Charles J, Fennerty M Brian, Dean Patrick J, Pleskow Douglas K, Chuttani Ram, Reymunde Alvaro, Santiago Nilda, Chang Kenneth J, Kimmey Michael B, Fleischer David E
Division of Gastroenterology and Hepatology, Mayo Clinic Scottsdale/Phoenix, Scottsdale, Arizona, USA.
Gastrointest Endosc. 2007 Feb;65(2):185-95. doi: 10.1016/j.gie.2006.09.033.
To assess the dose-response, safety, and efficacy of circumferential endoscopic ablation of Barrett's esophagus (BE) by using an endoscopic balloon-based ablation device (HALO360 System).
This study was conducted in 2 serial phases (dosimetry phase and effectiveness phase) to evaluate a balloon-based ablation device that delivers a pre-set amount of energy density (J/cm2) to BE tissue. The dosimetry phase evaluated the dose-response and the safety of delivering 6 to 12 J/cm2. The effectiveness phase used 10 J/cm2 (delivered twice [x2]) for all patients, followed by EGD with biopsies at 1, 3, 6, and 12 months. A second ablation procedure was performed if BE was present at 1 or 3 months. Patients received esomeprazole 40 mg twice a day for 1 month after ablation, and 40 mg every day thereafter. Postablation symptoms were quantified by using a 14-day symptom diary (scale, 0-100). A complete response (CR) was defined as all biopsy specimens negative for BE at 12 months.
Eight U.S. centers, between September 2003 and September 2005.
Patients were 18 to 75 years of age, with a diagnosis of BE (without dysplasia), with histopathology reconfirmation of the diagnosis within 6 months of enrollment.
In the dosimetry phase, 32 patients (29 men; mean age, 56.8 years) were enrolled. Median symptom scores returned to a score of 0 of 100 by day 3. There were no dose-related serious adverse events, and the outcomes at 1 and 3 months permitted the selection of 10 J/cm2 (x2) for the subsequent effectiveness phase of the study. In the effectiveness phase, 70 patients (52 men, 18 women; mean age, 55.7 years) were enrolled. Median symptom scores returned to a score of 0 of 100 by day 4. At 12 months (n = 69; mean, 1.5 sessions), a CR for BE was achieved in 70% of patients. There were no strictures and no buried glandular mucosa in either study phase (4306 biopsy fragments evaluated).
Circumferential ablation of nondysplastic BE by using this balloon-based ablation device can be performed with no subsequent strictures or buried glands and with complete elimination of BE in 70% of patients at 1-year follow-up.
使用基于内镜球囊的消融装置（HALO360系统）评估Barrett食管（BE）环形内镜消融的剂量反应、安全性和疗效。
本研究分两个连续阶段（剂量测定阶段和有效性阶段）进行，以评估一种能向BE组织输送预设能量密度（焦耳/平方厘米）的基于球囊的消融装置。剂量测定阶段评估6至12焦耳/平方厘米剂量的剂量反应和安全性。有效性阶段对所有患者使用10焦耳/平方厘米（分两次输送[x2]），随后在1、3、6和12个月时进行内镜检查及活检。如果在1或3个月时仍存在BE，则进行第二次消融手术。患者在消融后1个月内每天服用两次40毫克埃索美拉唑，之后每天服用一次40毫克。消融后症状通过14天症状日记（评分范围0 - 100）进行量化。完全缓解（CR）定义为12个月时所有活检标本BE均为阴性。
2003年9月至2005年9月期间的美国8个中心。
年龄在18至75岁之间，诊断为BE（无发育异常），入组后6个月内组织病理学再次确认诊断。
在剂量测定阶段，纳入32例患者（29例男性；平均年龄56.8岁）。症状评分中位数在第3天恢复至0（满分100）。无剂量相关严重不良事件，1个月和3个月时的结果允许在后续研究有效性阶段选择10焦耳/平方厘米（x2）。在有效性阶段，纳入70例患者（52例男性，18例女性；平均年龄55.7岁）。症状评分中位数在第4天恢复至0（满分100）。在12个月时（n = 69；平均1.5次治疗），70%的患者实现了BE的完全缓解。在两个研究阶段（共评估4306个活检碎片）均未出现狭窄和隐匿性腺体黏膜。
使用这种基于球囊的消融装置对无发育异常的BE进行环形消融，后续不会出现狭窄或隐匿性腺体，在1年随访时70%的患者BE完全消除。
