Endoscopic Therapy of Malignant Bile Duct Strictures: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Safety: Number of Bile Leak After RFA Procedure
研究概览
简要总结
Patients with malignant bile duct stenosis have poor prognosis and most of the patients are not good candidate for surgery at the time of diagnosis. Placement of the stent is the palliative care for these patients. However over 50% of the stents get blocked within 6-8 months. Use of the radiofrequency ablation before the stent placement may improve stent patency. Heat will be applied to the bile duct in order to open the blockage and prevent the re-growth of tissue into the stent. The investigators are looking to see how safe and feasible RFA (Radiofrequency ablation) catheter is in patient with malignant bile duct stenosis.
详细描述
As part of medical care subjects will be undergoing an endoscopic procedure (ERCP) in order to evaluate and stent a bile duct blockage. During the ECRP and just prior to the stent placement subjects will undergo the placement of a radiofrequency ablation catheter into the bile duct blockage. Heat will be applied to the bile duct in order to open the blockage and prevent the re-growth of tissue into the stent; after the radiofrequency ablation, stent will be placed. Three days after the procedure subjects will receive a phone call from the research coordinator to check any adverse or unwanted effects of the treatment. The study procedure (radiofrequency ablation) takes place over 10 minutes during ERCP. The subjects will undergo routine follow up for their medical problems. No follow up visits are required as part of the study.
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
- •Documented malignant biliary obstruction requiring ERCP guided stenting
排除标准
- •Coagulopathy (INR > 2.0 or PTT > 100 sec or platelet count < 50,000)
- •Evidence of high-grade symptomatic duodenal obstruction
- •Poor performance status
- •Active suppurative cholangitis
- •Complex stenoses will not be eligible for the trial
- •Patients without access to duodenum or ampulla are not candidates for ERCP and stenting
- •Candidates for a Whipple resection
- •Patients who do not speak English
结局指标
主要结局
Safety: Number of Bile Leak After RFA Procedure
时间窗: 2 years
Determination of safety will be measured by the presence of a bile leak( bile leak will be defined by contrast cholangiography)
次要结局
- Effectiveness: Change From Baseline in Bile Duct Diameter.(2 years)
- Feasibility: Ease of the Radiofrequency Ablation Catheter Placement(2 years)
研究者
William R. Brugge, MD
Principal Investigator
Massachusetts General Hospital