Percutaneous Cryoablation for the Palliation of Abdominal Pain Associated With Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 6
- 主要终点
- Abdominal pain reduction following cryoablation of the celiac plexus
研究概览
简要总结
CUC10-PAN09 will evaluate the safety and efficacy of cryoablation therapy on the relief of epigastric/abdominal pain associated with pancreatic cancer.
详细描述
CUC10-PAN09 is a Supportive Care, Phase 1 multicenter, prospective, single arm study with subjects serving as their own control. This study is to enroll patients who will undergo cryoablation of the Celiac Plexus. Subjects will be followed for 3 months post their cryoablation procedure.
Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal) and urology (kidney).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Subject must be at least 18 years old
- •Subject has unresectable or inoperable pancreatic carcinoma as determined by CT or MRI
- •Subject's epigastric/abdominal 'worst pain' in the last 24 hours must be reported to be 4 or above on a scale of 0 (no pain) to 10 (pain as bad as subject can imagine) on the BPI despite pharmaceutical pain management
- •ECOG of 0-3
- •Platelet count >50,000
- •INR <1.5
排除标准
- •Subject's life expectancy is <3 months
- •Subject has current neutropenia (ANC <1000)
- •Subject unable to undergo CT or MRI
- •Subject had previous ETOH neurolytic block for pancreatic cancer-related pain less than 2 weeks from screening
- •Subject had surgery <4 weeks from screening
结局指标
主要结局
Abdominal pain reduction following cryoablation of the celiac plexus
时间窗: 3 Months
Measured by the average difference of pre- and post-treatment worst pain in the last 24 hours (baseline), within 24 hours of the cryoablation procedure, 1 week, 4 weeks, 8 weeks and 12 weeks as measured on the numeric 0-10 Brief Pain Inventory (BPI) Scale
次要结局
- Cryoablation Procedure Information(During the procedure on the procedure day (an expected average of 3 hours))
- Difference in average pain scores(3 Months)
- Time to maximal epigastric/abdominal pain relief after cryoablation(3 Months)
- Time to recurrence of epigastric/abdominal worst pain at or above baseline(3 Months)
- Subject satisfaction with the amount of epigastric/abdominal pain relief from cryoablation procedure(3 Months)
- Duration of abdominal pain relief(3 Months)
- Hospital Duration(Participants will be followed for the duration of hospital stay, an expected average of 1 day)
- Safety assessment(30 Days post cryoablation)
- Percentage of subjects able to reduce analgesic medications(3 Months)