A Prospective Clinical Study of Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Small Benign Pancreatic Tumors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- To evaluate pancreatic tumor ablation effect
研究概览
简要总结
Incidental pancreatic solid or cystic lesions are diagnosed with increased frequency due to the widespread use of abdominal cross-sectional imaging to investigate unrelated symptoms. Lesions such as neuroendocrine tumors (NET), mucinous cystadenomas and intraductal papillary mucinous neoplasms (IPMNs) have the potential of malignant transformation. The standard treatment of solid or cystic pancreatic lesions with malignant potential has been surgical resection, with lesions in the pancreatic head requiring a Whipple resection whereas pancreatic tail lesions are treated with distal pancreatectomy. Both types of resection carry significant morbidity and mortality. The study would like to outline the feasibility, safety, adverse events and early results of endoscopic ultrasound (EUS) - radiofrequency ablation (RFA) in pancreatic neoplasms.
详细描述
The intervention described was radiofrequency ablation which was applied with an innovative monopolar radiofrequency probe (1.2 mm Habib EUS-RFA catheter) placed through a 19 or 22 gauge fine needle aspiration (FNA) needle once FNA was performed in patients with a tumor in the head of the pancreas. The device had been certificated by the European Union (EU) and received Food and Drug Administration (FDA) approval in 2015. The endoscopic ultrasound (EUS) - radiofrequency ablation (RFA) is a 1 Fr wire with a working length of 190 cm, which can be inserted through the biopsy channel of a EUS. RF power is applied to the electrode at the end of the wire to coagulate tissue in the liver and pancreas. In this study, the investigators will enroll 20 patients to receiving EUS-RFA of pancreatic neoplasms with the monopolar RF probe. The follow-up period will be one year with regular monitoring. Our primary endpoint will be to evaluate pancreatic tumor ablation effect, Secondary objectives will be to evaluate the mortality and morbidity.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following inclusion criteria to be eligible for this study:
- •Cystic neoplasms in pancreatic parenchyma or outer portion of the pancreas are defined by radiologists who evaluate the images more than twice in three months. The size of benign cystic neoplasm is between 0.5-3 cm. Or surgical specialist physician considers the benign tumor that larger than 3 cm is not suitable for surgery or patients unwilling to accept surgery.
- •Normal physical condition. Eastern Cooperative Oncology Group (ECOG) score of 0-2 and American Society of Anaesthesiologists (ASA) score ≤
- •Normal blood coagulation. Platelet count ≥ 100 K/Μl. Prothrombin time (PT)- international normalized ratio (INR) ≦ 1.
- •Prior Informed Consent Form.
- •Life expectancy of at least 3 months.
排除标准
- •Patients presenting with any of the following will not be enrolled into this study:
- •Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception.
- •To participate in any related tumor therapy clinical trials within thirty days prior to surgery.
- •Any active metal implanted device (eg Pacemaker)
- •Patients who have other malignancies and have not been cured within five years.
- •Patients with resectable pancreatic cancer.
- •Simple pancreatic cysts (including pseudocysts) or serous cystadenoma.
- •Cystic part of the tumor is close to blood vessels or bile duct (<0.5 cm) that might injury the related structure.
- •Cystic pancreatic tumors originate from or associate the pancreatic ducts.
- •Have acute pancreatitis in the past four weeks
- •Known history of human immunodeficiency virus (HIV) infection
- •Have cardiovascular diseases (such as acute myocardial infarction, or stroke) within the last three months
- •Moderate to severe renal dysfunction (Estimated Glomerular Filtration Rate (eGFR) <60)
- •Have any serious or poor control of systemic disease that are not suitable for this test and followup
研究组 & 干预措施
EUS-RFA
monopolar radiofrequency probe (1.2 mm Habib endoscopic ultrasound - radiofrequency ablation (EUS-RFA) catheter) and 19 or 22 gauge fine needle aspiration (FNA) needle
干预措施: endoscopic ultrasound - radiofrequency ablation (EUS-RFA) (Device)
结局指标
主要结局
To evaluate pancreatic tumor ablation effect
时间窗: up to one year
Using magnetic resonance cholangiopancreatography (MRCP) and/or abdominal computed tomography (CT)
次要结局
- Symptom and adverse event monitoring(up to one year)
- Physical examination(up to one year)
- Blood Routine (CBC)(up to one year)
- Biochemical profile(up to one year)