Endoscopic Radiofrequency Ablation of Celiac Ganglion for Pain Management and Improvement of Quality of Life in Patients With Unresectable Pancreatic Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Unresectable Pancreatic Cancer Endoscopic Ultrasound-guided Radiofrequency Ablation of Celiac Ganglion |
Procedure: Ablation of Celiac Ganglion
Endoscopic Ultrasound-guided Radiofrequency Ablation of Celiac Ganglion
|
Outcome Measures
Primary Outcome Measures
- Pain severity-BPI [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-VAS [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).
- Pain severity-NRS [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).
- Quality of Life (EORTC PAN26) [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.
- Quality of Life (EORTC C30) [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) [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.
- Concomitant Analgesic/Narcotic Use [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of pancreatic cancer based on clinical, radiological, or pathological assessment;
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Referred for abdominal and/or back pain due to pancreatic cancer;
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No prior history of RFA;
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Cancer pain unresponsive to the WHO 3-step analgesic ladder;
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Willingness to consent to participate in the study.
Exclusion Criteria:
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Patients who are not willing to give informed consent or agree to participate in the study
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Surgically resectable pancreatic cancer;
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Abdominal pain with etiology other than pancreatic malignancy;
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Evidence of concurrent infection;
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Patients with irreversible coagulopathy international normalized ratio >1.5 or platelet count <50,000/mm3),
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Patients with a preliminary diagnosis of adenocarcinoma are not possible established with intraprocedural at EUS-guided FNA.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shailendra Singh | Morgantown | West Virginia | United States | 26508 |
Sponsors and Collaborators
- West Virginia University
Investigators
- Principal Investigator: Shailendra Singh, MD, West Virginia University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2202520088