Endoscopic Ultrasound (EUS)-Guided Celiac Plexus Neurolysis (CPN) in the Management of Pain in Abdominal Non-pancreatic Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Difference between the mean pain score prior to and 1 month after the procedure, as determined by the Brief Pain Inventory (BPI)
研究概览
简要总结
Celiac plexus neurolysis (CPN) has been performed for nearly 100 years to alleviate the abdominal pain associated with pancreatic malignancy and other conditions, and is usually undertaken at a late stage in the disease process, when analgesic options have been largely exhausted or have led to significant and often unacceptable side effects. Until recently, CPN was most commonly performed under radiographic guidance; however, in the last 10 years, CPN has been routinely performed under endoscopic ultrasound (EUS) guidance. Several case series have demonstrated the efficacy and safety of this technique when used to treat the pain associated with pancreatic malignancy and/or chronic pancreatitis. However, the efficacy of EUS-guided CPN in the treatment of pain related to non-pancreatic malignancies has yet to be described. The goal of this study is to assess the efficacy of EUS-guided CPN in the management of pain in patients with abdominal non-pancreatic malignancies. Our hypothesis is that EUS-guided CPN will provide adequate pain relief in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Diagnosis of an unresectable, non-pancreatic malignancy, including gastric, small intestinal, or proximal colonic malignancies, as well as malignancies of the liver and bile ducts (based on above celiac plexus innervations)
- •Pain directly related to the primary malignant process, as determined by the referring oncologist
- •Pain determined to be refractory to standard medical therapy, or when the medical therapy is ineffective due to certain limitations (such as severe constipation), as determined by the referring oncologist
- •Willingness to undergo EUS-guided CPN
- •Age > 18 years
- •ECOG performance status of grades 0-3 [7]
- •The patient will need to sign informed consent prior to inclusion in this study
排除标准
- •Unable or unwilling to undergo an EUS-guided CPN
- •Contraindication to anesthesia, as determine during the preoperative clearance process
- •Refractory coagulopathy (INR > 1.5) or thrombocytopenia (platelet count < 50,000), or aspirin and/or clopidogrel use within 7 days of procedure
- •Current pregnancy
- •Prior celiac plexus block/neurolysis
- •Allergy to local anesthetics
- •ECOG performance status of grade 4 or higher
结局指标
主要结局
Difference between the mean pain score prior to and 1 month after the procedure, as determined by the Brief Pain Inventory (BPI)
时间窗: 1 month
The BPI will be filled out just prior to and 1 month after the procedure to assess the difference in the mean pain score after the procedure
次要结局
- Difference in the mean 'level of interference of pain with daily life' score, as determined by the Brief Pain Inventory (BPI). This score will be determined before and after the procedure, determined at the same intervals as mean pain scores.(2 months)
- Difference in mean pain scores before and at 1 day after the procedure, 7 days after the procedure, 14 days after the procedure, and at 2 months after the procedure, as determined by the Brief Pain Inventory (BPI).(2 months)
- Narcotic use over a 24-hour period will be documented each time the Brief Pain Inventory (BPI) is completed(2 months)
研究者
Rajesh Keswani
Asssociate Professor
Northwestern University