Investigation of the Effect of Intraductal Radiofrequency Ablation in Inoperable Biliopancreatic Tumors Complicated With Obstructive Jaundice
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Feasibility (ratio of technically successful RFA-applications to all examinations in which RFA-use was intended)
研究概览
简要总结
This phase-2 study aims to evaluate feasibility, safety and efficacy of thermal ablation of biliary obstructive malignancies by means of radiofrequency ablation (RFA, ELRA, StarMed) during endoscopic retrograde cholangio-pancreaticography (ERCP) with primary intent to obtain palliative biliary drainage via stenting
详细描述
INTRODUCTION
Biliary obstruction is the most relevant factor for survival and quality of life in patients suffering from primary bile duct malignancies or pancreatic head carcinoma. Due to their insidious course, these cancers are often diagnosed at an advanced stage. Thus, therapy is frequently restricted to palliative management. Within this setting, the prevention/treatment of biliary complications such as jaundice, cholangitis, or sepsis is one of the key therapeutic factors to extend survival and maintain quality of life (1-3). Endoscopic stenting of the biliary tract is now generally accepted as the primary approach to reestablish sufficient biliary drainage, provided approximately 50% of the liver parenchyma is drained (4). As the tumor grows, unfortunately, it often occurs that jaundice reappears despite primary stenting. Most oftenly this relates to unbridled tumor expansion leading to either stent-dysfunction by tumor ingrowth (through the mesh in case of metallic stenting of or via clogging of plastic stents) or either to extension in more proximal bile ducts/branches shutting of sufficient/adequate biliary drainage.
Given the context of incurable disease, a minimally-invasive strategy that could reduce the tumor burden in addition to stenting might be considered beneficial in terms of longer sustained bile duct drainage, and as such improve quality of life, more efficiently administered and better tolerated courses chemotherapy and delayed disease progression.
An example of such a potential minimal invasive strategy is RadioFrequency Ablation (RFA). It involves a modified electrocautery technique that has emerged among the many choices for local, minimally invasive tissue ablation. It has proven effective, versatile, and relatively inexpensive. RFA has been used for years in the treatment of cardiac dysrhythmias from aberrant conduction pathways, osteoid osteoma, prostate hypertrophy, and chronic pain (5-8). Recent clinical applications include tumor ablation in the liver (9-11), kidney (12,13) adrenal gland (14,15), bone (16), lung (17), and breast (18) as well as soft tissue debulking and pain palliation (19).
In the context of gastro-intestinal endoscopy, RFA has taken its place in the reduction of neoplastic progression of Barrett esophagus over 3 years of follow-up (20).
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
- •Male or female subjects with age above 18 years old
- •A confirmed diagnosis (endoscopic radiology, histology etc) of pancreatic or cholangiocarcinoma with obstructive jaundice considered inoperable according to multidisciplinary assessment
- •Willing and able to give written informed consent
排除标准
- •Refusal to consent or undergo ERCP
- •Less than 50% of liver parenchyma potentially drainable on pre-intervention imaging
- •Platelets < 40 x 109 mm3, an international normalized ratio (INR) > 1.5
- •Other concomitant disease or condition likely to significantly decrease life expectancy (e.g., moderate to severe congestive heart failure, severe COPD)
- •Portal vein thrombosis
- •18 patients to be included : Hilar cholangiocarcinoma : n=9 Distal cholangiocarcinoma/pancreatic cancer n=9
结局指标
主要结局
Feasibility (ratio of technically successful RFA-applications to all examinations in which RFA-use was intended)
时间窗: 90 days after index procedure
次要结局
- Quality of life (QuoL) by means of the EORTC QLQ-C15-PAL questionnaire after the procedure and at 30 and 90 days vs before(90 days after index procedure)
- 30-day-, 90-day and overall mortality(90 days after index procedure)
- Number of days and reasons for hospitalizations during the study period(90 day after index procedure)
- Efficacy measured by progression-free survival at 3 months upon standard follow-up imaging study and duration of stent patency (days) after the RFA-performed procedure(90 days after index procedure)
- safety (number and type of adverse events)(90 days after index procedure)
