NCT00583479已完成4 期
A Prospective Study of Celiac Block Technique: One Injection or Two?
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region
研究概览
简要总结
The purpose of this prospective randomized study is to compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region.
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
- Single (Participant)
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
- •Patients with chronic abdominal pain from documented chronic pancreatitis or pancreatic cancer that are referred for EUS-guided celiac block will be eligible to participate in this study. Chronic pancreatitis and pancreatic cancer must be measured and documented by prior CT, ERCP, or EUS.
- •Patients should not have significant co-morbidities such as uncontrolled heart failure, or severe chronic obstructive pulmonary disease (COPD) that would limit survivability of the sedation given or the procedure.
- •Age > or = to 18 years
- •No evidence of significant active infection (ie. pneumonia, peritonitis, wound sepsis, etc)
- •No evidence of serious ongoing illness such as uncontrolled metabolic disease (diabetes mellitus, hypothyroidism, etc)
- •No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol.
- •Patient must provide signed written informed consent.
- •Patients that have had a previous celiac plexus block are eligible for this study
排除标准
- •The patient's celiac trunk should be imaged clearly under endoscopic ultrasound. The patient's celiac plexus should be accessed easily with a needle for the medication injection. If this cannot be done safely due to the patient's anatomy (intervening blood vessel or tumor), the patient will not be eligible for the procedure or study.
研究组 & 干预措施
A
Other
subjects who get one medication injection into the celiac ganglion during the EUS
干预措施: one injection into the celiac ganglion (Other)
B
Other
subjects who get divided dose of the medication injected into two locations within the celiac ganglion during the EUS
干预措施: two injections into the celiac ganglion (Other)
结局指标
主要结局
Compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region
时间窗: 24-hour after the procedure; then every week thereafter until the subject is no longer in the study
次要结局
- change in medication use(at 24-hours after procedure and every week thereafter until the subject is no longer in the study)
- change is pain score(at 24-hours after procedure and every week thereafter until the subject is no longer in the study)
- complications related to CB(at 24-hours after procedure and every week thereafter until the subject is no longer in the study)
研究者
研究点 (1)
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