A Randomized Controlled Trial of Endoscopic Ultrasound Guided Celiac Plexus Neurolysis (EUS-CPN) With and Without Bupivacaine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Change in Likert pain scores
研究概览
简要总结
Endoscopic ultrasound (EUS) allows EUS-guided trans gastric injection of absolute alcohol around the base of the celiac plexus (celiac plexus neurolysis (EUS-CPN)), to help alleviate pain associated with pancreatic cancer.
It is standard procedure to inject bupivacaine immediately before injecting absolute alcohol, to theoretically prevent pain that may occur during and after the procedure. However, there are no data showing whether bupivacaine injection has any real influence on intra-procedural, immediate post-procedural, or long-term pain control. The injection of bupivacaine before the alcohol may have no effect, a synergistic effect, or an antagonistic effect, by diluting the alcohol, and reducing its neurolytic capacity. Inadvertent intravascular injection of bupivacaine may also cause irreversible cardiac arrhythmias and death.
The investigators therefore propose a randomized clinical trial to determine whether the exclusion of bupivacaine during EUS-guided CPN improves outcomes, or not.
详细描述
Pancreatic malignancies are the second most frequent gastrointestinal malignancy in Canada. From cancer mortality statistics in 2014, there were 4,700 new cases of pancreatic malignancies second only to colorectal cancer, representing 2.4% of all cancers. Even with chemotherapy, the median survival for patients with pancreatic adenocarcinoma is 6 to 10 months. Few patients are diagnosed at a resectable stage (12%-20%) so many patients are candidates for palliation only.
In this context, one of the most important symptoms is pain because it often affects both quality of life and survival. 70 to 80 % of patients with pancreatic cancer have abdominal pain at the time of diagnosis. Adequate pain control is therefore an essential component of care in these patients. In the initial phase, the pain is visceral, but with disease progression, somatic pain may occur, especially due to the peri-pancreatic invasion of neural structures, such as the celiac plexus.
Standard analgesics such as acetaminophen are usually ineffective and the use and effectiveness of opioids is frequently limited by side effects such as nausea, constipation, somnolence, confusion or respiratory depression.
The celiac plexus is immediately adjacent to the gastric wall. Endoscopic ultrasound (EUS) allows EUS-guided trans gastric injection of neurolytic agents around the celiac plexus (celiac plexus neurolysis [CPN]). Under conscious sedation, the echoendoscope is advanced into the stomach, just distal to the gastro-esophageal junction. The region of the celiac plexus is identified around the takeoff of the celiac artery from the aorta. Then, under real-time ultrasound guidance, a 19g needle is used to inject a neurolytic agent such as absolute alcohol around the base of the celiac artery. The entire procedure takes approximately 5 minutes. Absolute alcohol causes the immediate destruction of the celiac plexus neurons, by precipitation of endoneural lipoproteins and mucoproteins.
The effectiveness of CPN, is well established. It is safe, produces significant pain reduction, significantly reduces narcotic requirements, and may even increase survival. The investigators were the first to publish a randomized, sham-controlled trial demonstrating the efficacy of EUS-CPN for pain due to pancreatic cancer, and authored the most recent published guidelines on the use of EUS-CPN.
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, Care Provider)
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
- •Malignant-appearing pancreatic mass, or proven pancreatic cancer involving the pancreatic genu, body, or tail
- •Any level of abdominal or back pain considered to be potentially related to the mass:
- •New onset pain (<3 months)
- •Centrally located
- •With or without irradiation to the back
- •No obvious other source of pain based on history and physical examination by the attending endosonographer
- •No possibility of surgical management
- •Signed, informed consent
- •Celiac axis accessible for bilateral neurolysis at EUS.
排除标准
- •1. Allergy to bupivacaine
结局指标
主要结局
Change in Likert pain scores
时间窗: Day 0 and Day 30
Pain scale used : 7-point Likert scale for pain (minimum value is 0, maximum value is 6; higher scores mean a worse outcome)
次要结局
- Time to discharge from the endoscopy unit(From time of arrival in the recovery room after the intervention to time of discharge from the recovery room. The estimated period of time over which the event is assessed is up to two hours)
- Difference in pain scores at T0 vs all other follow-up time points(Days 0, 3, 7, 30, 60, 90, 120)
- Adverse events(Days 0, 3, 7, 30, 60, 90, 120)
- Narcotic usage(Narcotic usage for the 3 day-period preceding Days 0, 60 and 120)
- Survival(Up to 18 months)
- Difference in Global Rating Scale of Change at T3 vs all other follow-up time points(Days 3, 7, 30, 60, 90, 120)