Comparing the Effects of Coeliac Plexus Neurolysis Versus Splanchnic Nerve Neurolysis for Non-pancreatic Upper Intra-abdominal Cancer Pain: a Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- pain score
研究概览
简要总结
Pain is prevalent among patients with gastrointestinal cancers. Standard procedures such as coeliac plexus neurolysis (CPN) is effective in reducing pain, opioid requirement and related side effects for pancreatic cancer cases. Meanwhile, splanchnic nerve neurolysis (SNN) as an alternative to CPN is more effective for cancer pain relief.
Although previous studies investigating the role of CPN/SNN mainly focus on pancreatic cancer cases, their efficacy on non-pancreatic abdominal cancer pain may not be accurately determined.
详细描述
Pain is prevalent among patients with gastrointestinal cancers. There is abundant evidence that coeliac plexus neurolysis (CPN) is effective in reducing pain, opioid requirement and related side effects for pancreatic cancer cases while the evidence for other upper abdominal cancer pain is less robust but emerging. Meanwhile, there is an increasing interest in utilising splanchnic nerve neurolysis (SNN) as an alternative to CPN for cancer pain relief.
Although previous studies investigating the role of CPN/SNN involved heterogenous types of intra-abdominal malignancies, majority of cases were pancreatic cancer. Therefore, their efficacy on non-pancreatic abdominal cancer pain may not be accurately determined.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The patients and independent investigators collecting outcome data will be blinded.
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 unresectable intra-abdominal cancer
- •Visceral pain attributable to the cancer with NRS >= 4
- •Able to understand instructions, give consent, complete questionnaires
排除标准
- •Primary pancreatic cancer or metastatic disease involving pancreas
- •Gross celiac axis distortion identified on imaging
- •Acute abdomen condition eg. Intraabdominal sepsis, tumor rupture
- •Other non-cancer causes attributable to the pain
- •Gross ascites
- •Previous coeliac plexus or splanchnic nerve neurolysis
- •Contraindications to neurolytic procedures eg. Bleeding tendency; local or systemic infections; allergic to local anesthetics, contrast or alcohol; intestinal obstruction; anatomical distortion along needle trajectory
- •Patients believed to be inappropriate for study by investigators
结局指标
主要结局
pain score
时间窗: at one week after procedure
Pain intensity using numerical rating scale from 0 to 10 where 0 is no pain and 10 is the worst pain.
次要结局
未报告次要终点
研究者
Dr. Chan Chi-Wing
Honorary Clinical Associate Professor
The University of Hong Kong