Randomized Trial of EUS-guided Celiac Plexus Block vs. Sham for Palliation of Pain in Chronic Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Rate of adequate pain relief
研究概览
简要总结
The aim of this randomized trial is to assess the efficacy of EUS-CPB in the alleviation of abdominal pain in patients with chronic pancreatitis.
详细描述
Chronic pancreatitis is a complex fibroinflammatory disease arising from numerous etiological factors and a variety of clinical manifestations. Abdominal pain is the most debilitating complication and can result in significant morbidity and impact on quality of life. Endoscopic ultrasonography (EUS) has been increasingly utilized for celiac plexus block (EUS-CPB), whereby a steroid in combination with a local anesthetic agent are injected into the celiac plexus within the abdominal cavity. The aim of this randomized trial is to assess the efficacy of EUS-CPB in the alleviation of abdominal pain in patients with chronic pancreatitis.
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
- 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 years
- •Abdominal pain of at least 3 months duration and a VAS score ≥ 3, with or without the use of narcotic analgesics.
- •Diagnosis of chronic pancreatitis on EUS examination, with ≥ 5 features on EUS.
- •No other cause of abdominal pain
排除标准
- •Age < 18 years.
- •History of prior EUS-CPB.
- •Use of anticoagulants that cannot be discontinued for the procedure.
- •Clinically significant allergy to bupivacaine or triamcinolone.
- •Unable to obtain consent for the procedure from either the patient or LAR.
- •Intrauterine pregnancy.
结局指标
主要结局
Rate of adequate pain relief
时间窗: 1 month
Rate of adequate pain relief in patients with chronic pancreatitis undergoing endoscopic ultrasound-guided celiac plexus block or sham procedure. Adequate pain relief is defined as a 50% reduction in composite pain score from baseline, measured using the Brief Pain Inventory-Short Form, at 1 month post-intervention.
次要结局
- Disease-related adverse events(3 months)
- Length of hospitalization in any patient hospitalized(3 months)
- Hospital admissions for management of chronic pancreatitis.(3 months)
- Rate of need for any additional endoscopic, surgical or radiological intervention for chronic pancreatitis.(3 months)
- Technical success(Immediately after procedure)
- Pain scores measured using Visual Analog Scale.(3 months)
- Quality of life assessment(3 months)
- Opioid analgesic use(3 months)
- Procedure-related adverse events(3 months)
- Pain scores measured using the Comprehensive Pain Assessment Tool-Short Form.(3 months)
- Rate of cross-over to EUS-CPB in patients initially assigned to the sham group.(3 months)