NCT01615653已完成不适用
Prospective Randomized Trial of EUS Guided Celiac Ganglia Neurolysis (CGN) Versus EUS Guided Celiac Plexus Neurolysis (CPN) for Pancreatic Cancer Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Pain assessed using a numerical rating scale (NRS) from 0 to 10.
研究概览
简要总结
- Hypothesis:
- Direct CGN enhances neurolytic drug delivery into celiac ganglia and increases the efficacy of neurolysis and subsequent pain control and survival in patients with pancreatic carcinoma.
-
Rationale:
-
Standard CPN leads to inaccurate delivery of the injectate with rapid dispersal thereby only briefly remaining in contact with neural structures and limiting the degree of neurolysis. Poor targeting and delivery of a neurolytic agent may result in diminished neurolysis and decrease efficacy.
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, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unresectable pancreatic carcinoma (T4 or M1) or advanced T3 disease
- •Cytologic or histologic confirmation of pancreatic carcinoma
- •Abdominal pain (≥ 3 on NRS scale), ≥ 2 days/week, lasting ≥ 1 hour/ day, stable intensity for ≥ 7 days
- •EUS clinically indicated (for non-study purposes)
排除标准
- •Uncorrectable coagulopathy: (INR) > 1.5 and/or platelets < 50,000
- •Abdominal surgery within 1 month
- •Prior celiac plexus or ganglia neurolysis.
- •Initiation or modification in chemotherapy or radiotherapy within prior 7 days.
- •Direct tumor infiltration of the celiac trunk and/or celiac ganglia.
结局指标
主要结局
Pain assessed using a numerical rating scale (NRS) from 0 to 10.
时间窗: Baseline to 6 months
pain response will be measured
次要结局
未报告次要终点
研究者
研究点 (2)
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