NCT03769753已完成2 期
Trial Of IRE in Cholangiocarcinoma (TOnIC): Phase II
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 13
- 主要终点
- Number of Patients Experiencing a Clinically Relevant Complications
研究概览
简要总结
The purpose of this study is to test any good and bad side effects of surgery using IRE to treat cancer of the bile duct.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Capable of providing written and oral informed consent in English
- •Locally advanced disease based on preoperative work-up demonstrating that the tumor is unresectable due to portal vein, hepatic artery, and/or bile duct involvement, insufficient hypertrophy response of the future liver remnant after portal vein embolization, or patients not able to tolerate major liver surgery
- •Found to be unresectable intraoperatively based on vascular, biliary, or lymph node (N2) involvement upon exploratory laparotomy
- •Patients will be assessed for chemotherapy prior to treatment with IRE, but given the common problem of recurrent cholangitis, some patients will not be candidates for chemotherapy until after IRE is performed.
排除标准
- •Locally advanced PHC eligible and accepted for liver transplantation evaluation
- •PHC with > 5 cm extension along the common hepatic duct or common bile duct on preoperative imaging or intraoperative ultrasound
- •Metastases to peritoneum, liver or other organs confirmed by percutaneous biopsy, staging laparoscopy or intraoperative frozen section
- •Lymph node metastases beyond N2 stations, confirmed by intraoperative frozen sections or radiographic diagnosis
- •History of cardiac disease:
- •Congestive heart failure (NYHA class >2)
- •Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening)
- •Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers are permitted)
- •Any implanted stimulation device (defined as implantable cardiac device and a pacemaker)
- •Uncontrolled hypertension (blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen)
- •Uncontrolled infections (> grade 2 NCI-CTC, version 3.0)
- •Both narrowing (sclerosis) of the main portal vein and a reduced diameter of either the common hepatic artery, celiac trunk or superior mesenteric artery of >50%
结局指标
主要结局
Number of Patients Experiencing a Clinically Relevant Complications
时间窗: within 30 days post-IRE
defined as CTCAE (version 5.0) grade 3 or higher complications
次要结局
未报告次要终点
研究者
研究点 (13)
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