A Randomized Controlled Trial of Intraoperative Chemical Splanchnicectomy for Patients With Resected Pancreatobiliary Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Pain Control
研究概览
简要总结
This is a randomized study of surgery plus chemical nerve block versus surgery plus placebo for pain control in subjects with pancreatic cancer.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Placebo Injection
Celiac plexus injection - placebo injection
干预措施: Placebo Injection (Other)
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
干预措施: Alcohol Injection (Other)
结局指标
主要结局
Pain Control
时间窗: 12 Months
次要结局
- Disease-specific, recurrence-free survival(2 Years)
研究者
Michael G. House
Associate Professor of Surgery
Indiana University