Phase III Randomized Placebo Controlled Trial of EUS Guided Celiac Plexus Neurolysis for Pancreatic Cancer Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- To evaluate the efficacy of treatment of ethanol injection versus placebo
研究概览
简要总结
This is a clinical trial to determine more effective methods of controlling the pain in pancreatic cancer. Although narcotic pain medication are effective, they have many side effects and are underutilized due to social stigma and fear of addiction. Celiac plexus neurolysis is a nerve block procedure that has been shown to be effective in uncontrolled clinical trials. We hypothesized that celiac plexus neurolysis plus pain medication will be more effective and have fewer side effects than pain medication alone. We are evaluating the effectiveness of this standard pain medications with or without celiac plexus neurolysis in a randomized controlled trial. One half of the participants will receive pain medications only and the other half will receive pain medications plus neurolysis, delivered via an endoscopic ultrasound device placed in the stomach.
详细描述
This is a phase III randomized blinded sham controlled trial of endoscopic ultrasound guided celiac plexus neurolysis. Patients with pancreatic cancer who are unresectable and who have significant pain (> 3 on 0-10 scale) will be enrolled. At the time of a staging endoscopic ultrasound, patients will be randomized to celiac neurolysis or sham (injection of same medication into lumen of stomach). Neurolysis will be performed using standard bupivicaine and ethanol. Patients will be followed for at least 3 months for pain, quality of life and narcotic usage.
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
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3.1 Unresectable (T4 or M1 or non-regional lymph nodes) or inoperable (due to medical comorbidity) carcinoma of the pancreas as determined by CT or EUS. Patients with extensive portal vein or superior mesenteric vein involvement (T3 by 6th Ed. AJCC staging manual) will be included only if the consulting surgeon feels the patients is unresectable based on the CT scan information.
- •3.2 Presence of mid-abdominal pain ( 3 on VAS scale) at least 2 days per week, lasting at least 1 hour per day.
- •3.3 No known coagulopathy as measured by Prothrombin time (INR) 1.
- •Pre-EUS INR is not required unless clinically indicated due to known warfarin use or suspected coagulopathy.
- •3.4 Patient must not require more than 2 l/min oxygen supplementation to maintain saturation >90%.
- •3.5 > 6 months since previous myocardial infarction or angina. 3.6 ≥ 4 weeks since previous surgery. 3.7 No institution or change in chemotherapy or radiotherapy within 7 days prior (or 14 days post) ESU-CPN. See section 7.0 and 7.1 for details of chemotherapy and radiotherapy allowances.
- •3.8 Platelets ≥ 50,
- •Pre-EUS CBC is not required unless clinically indicated due to known or suspected coagulopathy.
- •3.9 Life expectancy > 3 months 3.10 Signed and dated informed consent.
排除标准
- •Unable to sign informed consent
结局指标
主要结局
To evaluate the efficacy of treatment of ethanol injection versus placebo
injection for pain in pancreatic cancer patients at 1 month and 3 months.
次要结局
- To evaluate mortality and surgical morbidity at 1 month and 3 months
- To evaluate magnitude of narcotic use after treatment at 1 month and 3 months
- To estimate the period of time pain scores will remain below baseline levels
- To estimate the effect of treatment on quality of life at 1 month and 3 month