Randomized, Controlled Trial of Endoscopic Ultrasound-Guided Bilateral Celiac Plexus Neurolysis vs Celiac Ganglia Neurolysis to Control Pain in Inoperable Pancreatic Cancer Patients With Inadequate Pain Control by Pain Killer
试验速览
- 阶段
- 不适用
- 入组人数
- 166
- 主要终点
- percentage of participants with 50% decrease or less than 3 points in Pain Visual Analogue Scale (VAS)
研究概览
简要总结
Pancreatic cancer related pain can be difficult to control, even with high doses of narcotics, whose adverse effects may further impair quality of life. So EUS-CPN(endoscopic ultrasound guided celiac plexus neurolysis) is well established as an effective technique for controlling pain and reducing narcotic requirements in patients with pancreatic cancer. Recently, celiac ganglia can be visualized and accessed by endoscopic ultrasound. So it allows for direct injection into individual celiac ganglia to perform celiac ganglia neurolysis. This more precise delivery of therapeutic drug will offers the potential for enhanced efficacy and safety. To evaluate this hypothesis, this randomized controlled trial aimed to compare the efficacy and safety of EUS-CGN(Endoscopic ultrasound guided celiac ganglia neurolysis) vs. Bilateral EUS-CPN(Endoscopic ultrasound guided celiac plexus neurolysis) in providing relief from pancreas cancer-related pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 19 years old age (above 70 years old age, need the consent of the legal representative)
- •Inoperable pancreatic cancer patients
- •Pancreatic cancer patients with inadequate pain control by pain killer (VAS score 4 points or more)
- •Patient who agree to participate in this study
排除标准
- •Abnormal clotting (international normalized ratio ≥1.5)
- •Reduced platelet count (≤50000/μL)
- •Use of anticoagulation agents
- •Presence of gastric and/or esophageal varices
- •Anatomical deformity due to past surgery
研究组 & 干预措施
EUS-CPN group
Group that be performed by Endoscopic ultrasound guided bilateral celiac plexus neurolysis
干预措施: EUS-CPN (Procedure)
EUS-CGN group
Group that be performed by Endoscopic ultrasound guided celiac ganglia neurolysis
干预措施: EUS-CGN (Procedure)
结局指标
主要结局
percentage of participants with 50% decrease or less than 3 points in Pain Visual Analogue Scale (VAS)
时间窗: 1 week after procedure
次要结局
未报告次要终点
研究者
Jong Kyun Lee
Professor, Department of Gastroenterology, Sungkyunkwan University School of Medicine, Samsung Medical center
Samsung Medical Center