EUS Guided Injection of Albumin Bound Paclitaxel Into Pancreatic Cysts
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 主要终点
- Frequency of Pancreatitis
研究概览
简要总结
This research study is a pilot study. In this pilot study we are testing the safety of a procedure. "Investigational" means that the Albumin bound paclitaxel (Abraxane) is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved Abraxane injection for your type of medical condition. Treatment of pancreatic cysts often requires follow-up imaging studies and surgical resection of the cysts. As part of standard medical care, you will be undergoing a diagnostic endoscopic ultrasound guided fine needle aspiration (EUS-FNA) in order to evaluate type of the cyst. During the EUS and just after the cyst fluid aspiration, you will undergo the injection of the drug into the cyst cavity if your cyst is thought to be cancerous or precancerous. Cyst fluid will be analyzed for further diagnosis.
详细描述
You will be asked to undergo some screening tests or procedures to find out if you can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. Screening tests include the following: medical history, performance status, assessment of pancreatic cyst by CT, MRI or EUS, blood tests and a pregnancy test.
If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria you will not be able to participate in this research study.
As part of your medical care you will be undergoing an endoscopic procedure EUS-FNA (Endoscopic Ultrasound Fine Needle Aspiration) in order to evaluate and evacuate the cyst fluid. During the EUS-FNA and just after the cyst fluid aspiration, albumin bound paclitaxel will be injected into the cyst cavity.
The study procedure (injection of drug into cyst cavity) takes place over 5 minutes during the EUS-FNA. 2 days after the procedure you will receive a phone call from the research coordinator to check on how you are feeling. 3 months after study procedure participants will undergo a follow up CT to see what happened to the cyst. You will continue to have routine follow up for your medical problems.
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
- •Mucinous cysts (premalignant or malignant cysts of the pancreas)
- •Normal organ and marrow function
- •Baseline CT within 6 months of enrollment
排除标准
- •Pregnant or breastfeeding
- •Acute active pancreatitis
- •Complicated pancreatic cysts
- •Subjects who do not speak English
研究组 & 干预措施
Albumin bound paclitaxel
Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
干预措施: Albumin bound paclitaxel (Drug)
结局指标
主要结局
Frequency of Pancreatitis
时间窗: 3-10 months (median 6 months) after injection therapy
Safety of injection of albumin-bound paclitaxel will be measured by the frequency of pancreatitis.
次要结局
- Feasibility of Endoscopic Ultrasonography (EUS) Guided Injection of Albumin-bound Paclitaxel Into Pancreatic Cysts(immediately after procedure)
- Size of Cystic Lesion(3-10 months (median 6 months) after injection therapy)
研究者
William R. Brugge, MD
Principal Investigator
Massachusetts General Hospital