Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control
A Randomized Controlled Trial of Intraoperative Chemical Splanchnicectomy for Patients With Resected Pancreatobiliary Malignancies
研究概览
详细说明
Thi is a study of pain control in subjects undergoing surgery for pancreatic or bile duct cancer.
Subjects undergoing surgery will be randomized to surgery plus celiac plexus neurolysis with ethanol injection versus surgery plus placebo injection. Subjects will be followed every three months for survivorship or death to assess pain, quality of life measures, and narcotic pain control usage. The primary endpoint of pain control will be determined at one year post surgery. Subjects are not required to undergo any additional diagnostic testing procedures that are not part of their routine follow-up care.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Indiana
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Indianapolis、Indiana、美国、46202
- Indiana University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
This study will be offered to all patients scheduled to undergo open or laparoscopic operative resection of a presumed pancreatic (any location; i.e., head, body, or tail) or distal biliary tract cancer.
- Physiologic suitability for major abdominal surgery
- Aged 18 years and older
- Written informed consent
- Ability to understand and comply with study guidelines.
Exclusion Criteria:
- Pregnancy
- Previous, preoperative celiac nerve block
- Neoadjuvant chemotherapy or radiation therapy
- Incomplete tumor resection (R2 resection, grossly positive resection margin)
- Presumed ampullary or duodenal cancer based on preoperative work-up or intraoperative findings
- Benign tumors, neuroendocrine tumors, soft tissue tumors based on preoperative work-up or intraoperative findings
- Known metastatic disease
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Alcohol Injection
Celiac plexus neurolysis by alcohol injection One time administration during surgery 20 ml of alcohol injection on each side of aorta at level of celiac axis
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Celiac plexus neurolysis by alcohol injection
其他名称：
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安慰剂比较：Placebo Injection
Celiac plexus injection - placebo injection
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其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Pain Control
大体时间：12 Months
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12 Months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Disease-specific, recurrence-free survival
大体时间：2 Years
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2 Years
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合作者和调查者
调查人员
- 首席研究员：Michael G House, MD、Indiana University, Department of Surgery
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.