A Randomized, Controlled Trial of Intraoperative Celiac Plexus Neurolysis for Patients With Operable (Resectable and Unresectable) Pancreatic and Periampullary Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 438
- 试验地点
- 1
- 主要终点
- The primary endpoint is cancer related pain control.
研究概览
简要总结
Determine if the addition of an intraoperative ethanol celiac plexus neurolysis (alcohol block) in patients undergoing surgical intervention for pancreatic cancer will result in a decrease in cancer associated pain
详细描述
Pancreatic adenocarcinoma is the fourth leading cause of cancer related death in the United States and is usually fatal. Surgery provides the only chance for long-term survival. Pain is a significant, often difficult to control component of survivorship for many who succumb to this disease. The purpose of this trial is to evaluate the effect of ethanol celiac plexus neurolysis (alcohol nerve block) in patients undergoing surgical intervention for pancreatic cancer. Patients undergoing surgery for pancreatic cancer will be enrolled in a prospective randomized double blind placebo controlled clinical trial.
This protocol is designed to definitively determine the role of ethanol celiac plexus neurolysis as a simple addition to the surgical management of pancreatic adenocarcinoma and help define the standard of care for cancer associated pain management in this disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Preoperative imaging indicates possibility of resectable pancreatic cancer
- •Intraoperative biopsy histologically confirming pancreatic adenocarcinoma
排除标准
- 未提供
研究组 & 干预措施
50% Ethanol
Operating surgeon injects 20 ml of 50% ethanol on each side of the aorta at the level of the celiac axis with a 20 or 22 gauge spinal needle
干预措施: Alcohol Block (Procedure)
Placebo
Operating surgeon injects 20 ml of saline on each side of the aorta at the level of the celiac axis with a 20 or 22 gauge spinal needle
干预措施: Alcohol Block (Procedure)
结局指标
主要结局
The primary endpoint is cancer related pain control.
时间窗: Increased pain at 12 months in subjects with resectable tumors; increased pain at 3 months in subjects with unresectable tumors
次要结局
未报告次要终点