NL-OMON50469已完成2 期
Ablation with irreversible electroporation in patients with advanced perihilar cholangiocarcinoma - a multicenter phase I/II safety study - ALPACA study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Age 18 years or older
- •* Capable of providing written and oral informed consent
- •* Meets criteria for advanced PHC
- •o Local recurrent disease localized on the distal bile duct remnant,
- •hepatico-jejunostomy or in the liver hilum without N2 lymph nodes or distant
- •metastases .
- •* Diagnosis of PHC or lymph node metastases must be confirmed with endoscopic
- •brush, percutaneous- or laparoscopic biopsy, whichever is suitable, o Vascular
- •or lymph node (N2) involvement on imaging or during staging laparoscopy
- •Diagnosis of PHC or lymph node metastases beyond N2 stations
- •must be confirmed with endoscopic brush,
- •percutaneous- or laparoscopic biopsy, whichever is suitable
- •o Vascular or lymph node (N2) involvement during exploratory laparotomy
- •Must be confirmed with intra-operative frozen section
排除标准
- •* Resectable PHC upon exploratory laparotomy
- •* Locally advanced PHC eligible for liver transplantation (Appendix 3)
- •* PHC with > 5 cm extension along the common hepatic duct or common bile duct
- •* Metastases to peritoneum, liver or other organs confirmed by percutaneous
- •biopsy, staging laparoscopy or intraoperative frozen section
- •* Lymph node metastases beyond N2 stations (e.g. inguinal, mediastinal)
- •* History of cardiac arrhythmia*s (any of the following)
- •o Sinus tachycardia (BPM>100)
- •o Sick sinus syndrome
- •o Sinoatrial exit block
- •o Sinus node reentry
- •o Presence of a pacemaker or defibrillator
- •* Recent history of myocardial infarction (<6 maanden)
- •* 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)
- •* Epilepsy
- •* Both narrowing (sclerosis) of the portal vein and a reduced diameter of
- •either the common hepatic artery, celiac trunk or superior mesenteric artery of
- •* Any condition that is unstable or that could jeopardize the safety of the
- •subject and their compliance in the study
研究者
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