NL-OMON40224已完成2 期
Irreversible electroporation treatment in patients with pancreatic locally advanced adenocarcinoma - IMPALA
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
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
- •- Physically fit to undergo explorative laparotomy
- •- Pancreatic cancer confirmed with pathology (either pre- or intraoperative, pathological diagnosis must be either pancreatic adenocarcinoma or non-intestinal cholangiocarcinoma located in the pancreas) and non resectability because of locally advanced growth (stage III) during surgical exploration
- •- One of the following:
- •* Potentially resectable panreatic cancer based on imaging and planned for surgical exploration with intend for resection, this includes 2 groups of patients
- •* Patients with resectable disease at primary evaluation but are considered non-resectable during surgical exploration
- •$ Patients with initially non-resectable disease because of locally advanced pancreatic cancer without metastases, who have stable or regressive (non-metastasized) disease after 3 months of chemotherapy
- •* Locally advanced pancreatic cancer based on imaging without options for non-operative drainage of stomach and bileducts and therefore planned for surgical exploration with intend for bypass surgery
排除标准
- •- Resectable pancreatic cancer during explorative laparotomy
- •- Presence of metastatic disease (peritoneal, liver or other)
- •- Pathological diagnosis of intestinal-type cholangiocarcinoma
- •- History of cardiac arrhythmia*s
- •* Sinus tachycardia (BPM>100)
- •* Sick sinus syndrome
- •* Sinoatrial exit block
- •* AV block
- •* Sinus node reentry
- •* Presence of a pacemaker or defibrillator
- •- Recent history of myocardial infarction
- •- History of epilepsy
- •- Partial portal vein thrombosis
- •- Both narrowing (sclerosis) of the portal vein and a reduced diameter of either the common hepatic artery, celiac trunc or superior mesenteric artery of >50%
研究者
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