Endoscopic Ultrasound-guided Radiofrequency Ablation of Celiac Ganglion for Pain Management and Improvement of Quality of Life in Patients With Unresectable Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Quality of Life (EORTC C30)
研究概览
简要总结
This study aims to evaluate the EUS-RFA in terms of efficacy for pain management and improvement in quality-of-life parameters for patients with advanced inoperable pancreatic cancer. The primary objectives of this study are to 1) evaluate the utility of EUS-RFA for pain control and improvement in quality-of-life parameters for patients with advanced pancreatic cancer; 2) to measure the reduction of analgesic medications' requirements in patients affected by inoperable pancreatic cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 pancreatic cancer based on clinical, radiological, or pathological assessment;
- •Referred for abdominal and/or back pain due to pancreatic cancer;
- •No prior history of RFA;
- •Cancer pain unresponsive to the WHO 3-step analgesic ladder;
- •Willingness to consent to participate in the study.
排除标准
- •Patients who are not willing to give informed consent or agree to participate in the study
- •Surgically resectable pancreatic cancer;
- •Abdominal pain with etiology other than pancreatic malignancy;
- •Evidence of concurrent infection;
- •Patients with irreversible coagulopathy international normalized ratio >1.5 or platelet count <50,000/mm3),
- •Patients with a preliminary diagnosis of adenocarcinoma are not possible established with intraprocedural at EUS-guided FNA.
研究组 & 干预措施
Unresectable Pancreatic Cancer
Endoscopic Ultrasound-guided Radiofrequency Ablation of Celiac Ganglion
干预措施: Ablation of Celiac Ganglion (Procedure)
结局指标
主要结局
Quality of Life (EORTC C30)
时间窗: From Baseline up to 3 Months
Changes in Quality of Life as scored with the EORTC Quality of Life Questionnaire core questionnaire (C30). This measure uses a Likert type scale 1-4 with 1=better and 4=worse.
Quality of Life (NFHSI)
时间窗: From Baseline up to 3 Months
Changes in Quality of Life as scored with the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Hepatobiliary-Pancreatic Symptom Index (NFHSI). This measure uses a Likert type scale 0-4 with 0=no symptoms and 4= worst symptoms.
Pain severity-BPI
时间窗: From Baseline up to 3 Months
Change in severity of pain will be assessed using a standardized the Brief Pain Inventory-Short Form (BPI) ranging from 0 (no pain) to 10 (worst pain possible).
Pain severity-NRS
时间窗: From Baseline up to 3 Months
Change in severity of pain will be assessed using numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain possible).
Pain severity-VAS
时间窗: From Baseline up to 3 Months
Change in severity of pain will be assessed using visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst pain possible).
Concomitant Analgesic/Narcotic Use
时间窗: From Baseline up to 3 Months
Percent change in concomitant analgesic therapy will be evaluated. Details on the dose and frequency of opioid medications administered within 24 hours before the intervention will be collected and at different follow-up intervals after the procedure. The total dose of analgesic therapy administered will then be converted into an oral morphine equivalent dose for comparison.
Quality of Life (EORTC PAN26)
时间窗: From Baseline up to 3 Months
Changes in Quality of Life as scored with the Europen Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire pancreatic cancer module (PAN26). This measure uses a Likert type scale 1-4 with 1=better and 4=worse.
次要结局
未报告次要终点
研究者
Shailendra Singh
Associate Professor & Director, Bariatric Endoscopy
West Virginia University