Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Unresectable Pancreatic Adenocarcinoma - a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in serum levels of Ca 19-9
研究概览
简要总结
the study evaluate the efficacy and safety of EUS-RFA using Habib EUS-RFA catheter with a prospective randomised trial in patients with inoperable PDAC.
详细描述
The five year survival for pancreatic ductal adenocarcinoma (PDAC) is less than 5% in spite of the advances in management of cancers in the last few decades. Endobiliary application of radiofrequency ablation (RFA) has been developed in our unit and used in patients with unresectable bile duct and pancreatic head adenocarcinomas presenting with biliary obstruction. Various techniques of EUS-guided tumour ablation have been described, including RF ablation, photodynamic therapy, laser ablation, and ethanol injection. Endoscopic ultrasound guided RFA (EUS-RFA) of the pancreatic head using Habib EUS-RFA catheter through a 19-gauge needle was well tolerated in 5 Yucatan pigs and with minimum amount of pancreatitis .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients in the age group 20 to 80 years
- •A cytological or histological diagnosis of inoperable PDAC based on multidisciplinary review of cross sectional imaging and cytology or histology results.
- •Patients who have been deemed unfit for surgical resection of the PDAC subjects who are fit for surgical resection but have declined surgery will also be considered for the study
- •PDAC patients presenting with jaundice to be considered after a successful biliary drainage
- •Patients ought to be fit enough to be considered for the study (ECOG performance status 0, 1 or 2)
- •Patients capable of giving informed consent
排除标准
- •Inability to give informed consent
- •Pregnancy or breast feeding
- •ECOG performance status 3 or 4
- •Life expectancy less than 3 months
- •Patients with distant metastases or malignant ascites
结局指标
主要结局
Change in serum levels of Ca 19-9
时间窗: 60 days
Serum levels of Ca 19-9 was compared before and after 60 days EUS-RFA
Change in tumour size as measured on EUS and or CT
时间窗: 60 days
The tumor size was compared before and after 60 days EUS-RFA
次要结局
- Overall survival at 12 months(12 months)
- Overall survival at 6 months(6 months)
研究者
Jianfeng Yang
Associate director of gastroenterology department
First People's Hospital of Hangzhou