Endoscopic Ultrasound Guided Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Intractable Pain Due to Malignancy A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
Many cancer patients suffer from intractable pain and which is often suboptimally controlled by even strong opioid analgesics. Coeliac plexus neurolysis (CPN) is procedure which intended to permanently destroy the nociceptive pathway that transmits the pain caused by the tumour. It can be with different approaches, such as percutaneously guided by fluoroscopy, echo-endoscopically or surgically with endoscopic approach being the more popular one in many centers equipped with echo-endoscopic services. The effect of CPN has been well established by some retrospective series. The overall response rate to CPN ranges from 70-90%, however, the analgesic effect is limited and up to roughly around 3 months. It is believed that the short-lasting analgesic effect is related to incomplete neurolysis by absolute alcohol injection.
Recently, radiofrequency ablation (RFA) of coeliac plexus has been introduced as another mode of CPN. So far, only one small single center randomized controlled trial (RCT) suggesting superior performance in favour to CPN using RFA. This result has to be validated and by a RCT with larger sample size. In addition, data concerning the quality of life (QOL) improvement and cost-effectiveness need to be further elucidated. Therefore, the aim of this study is to perform a RCT to look into these issues.
详细描述
The aim of this study is to compare the efficacy of EUS-guided CPN versus radiofrequency ablation in patients with pain related to pancreatic cancer. By performing a randomized controlled trial, the clinical outcomes and cost-effectiveness of this new RFA treatment approach can be evaluated.
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
- 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
- •Age ≥18 year-old
- •Patients who give informed consent to the study
- •Suboptimal pain control with regular analgesics
- •Inoperable cancer of pancreas
排除标准
- •Patients who refuse to give consent
- •Patients aged <18 years
- •EUS not possible due to:
- •Problem related to scope insertion such as trismus, stenosis of the upper GI tract Coagulopathy with INR >1.5 or platelet count < 70
- •Low oxygen saturation or extreme blood pressure render endoscopic procedure unsafe
研究组 & 干预措施
EUS-CPB
Chemical ablation of the coeliac plexus
干预措施: 98% dehydrated alcohol (Drug)
EUS-CPA
Radiofrequency ablation of the coeliac plexus
干预措施: 19G EUSRA needle, Taewoong Medical, Korea (Device)
结局指标
主要结局
Pain score
时间窗: 4 weeks
Pain score at 4 weeks after procedure (by VAS score)
次要结局
- Clinical success rate(2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks)
- Technical success rate(2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks)
- Cost-effectiveness of two types approach(Through study completion, an average of 2 year)
- Time to pain score drop by 50%(Through study completion, an average of 2 year)
- Short term complication rate(Up to 1 week)
- Long term complication rate(Through study completion, an average of 2 year)
- Hospital length of stay(Up to 100 months)
- Health status (Quality of life)(2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks)
- Quality of life (QOL) in patients with pancreatic cancer(2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks)
- Quality of life (QOL) of cancer patients(2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks)
- Duration of procedure(Up to 1 hour)
研究者
Dr. Ma Ka Wing
Clinical Assistant Professor
The University of Hong Kong