Multi-center Prospective Study on EUS-guided Radiofrequency Ablation for Solid Abdominal Neoplasms.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Severe adverse events
研究概览
简要总结
Radiofrequency ablation has been used for treatment of solid neoplasms of the liver, lung, kidney and adrenal. Recently, EUS-guided RFA has become available and the device allows EUS-guided treatment of solid abdominal neoplasms. The procedure has been shown to be feasible in the porcine pancreas and was used to treat small groups of patients that are not suitable for surgery suffering from pancreatic cancers.
The aim of the current study is to perform a multi-center prospective study on EUS-guided radiofrequency ablation (RFA) of solid abdominal neoplasms. The hypothesis is that EUS-guided RFA is safe, feasible and effective for treating solid abdominal neoplasms.
详细描述
RFA causes tissue destruction through the application of a high frequency alternating current, generating local temperatures above 60°C and leading to coagulative necrosis. The technique has been widely used in many solid organ tumours and has been shown to result in 5-year survival rates comparable to surgery. The technique is currently the standard therapy in hepatocellular carcinoma and colorectal pulmonary metastasis particular in patients that are not suitable for surgery.
The current study would be a multi-center prospective study involving four high volume international institutions. Consecutive patients suffering from solid neoplasms of the liver, stomach and adrenals would be recruited. EUS-guided RFA would be performed using a 19-gauge RFA electrode and a VIVA RF generator (STARmed, Korea). The primary outcome would be the overall adverse events rate. Secondary outcomes include mortality, technical success rate, completion ablation rate, 1 & 3 year overall and disease-free survival.
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-old or above
- •Suffering from solid neoplasms of the stomach, liver, kidney or adrenals (<5cm in largest diameter) that is indicated for treatment.
- •Unsuitable for surgery, due to one (or more) of the following items:
- •ASA score > II*
- •An alternative advanced malignancy
- •Unsuitable for surgery upon expert's opinion for any other reason
- •Healthy individuals who are not keen for surgical resection
- •Eligible for endoscopic intervention
- •Written informed consent
排除标准
- •Coagulopathy (international normalized ratio >1.3, partial thromboplastin time greater than twice that of control), platelet count <50,000x103/uL
- •Pregnancy
- •Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study
- •Patients unwilling to undergo follow-up assessments
- •Patients with liver cirrhosis, portal hypertension and/or gastric varices.
结局指标
主要结局
Severe adverse events
时间窗: 30 days
Adverse events specific to RFA would be graded according to the lexicon of endoscopic adverse events 24. Potential adverse events specific to RFA include: post-RFA syndrome, pancreatitis, pancreatic leak and thermal injury.
次要结局
- Radiological response(1 year)
- Number of re-interventions(1 year)
- Procedural times(1 day)
- Hospital stay(30 days)
- Technical success rates(1 week)
- Survival(3 years)
研究者
Anthony Teoh
Professor
Chinese University of Hong Kong