Endoscopic Radiofrequency Ablation of Celiac Ganglion for Pain Management and Improvement of Quality of Life in Patients With Unresectable Pancreatic Cancer

Study Overview
=================
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.

Official Title
-----------------
Endoscopic Ultrasound-guided Radiofrequency Ablation of Celiac Ganglion for Pain Management and Improvement of Quality of Life in Patients With Unresectable Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Procedure: Ablation of Celiac Ganglion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Unresectable Pancreatic Cancer<br>Endoscopic Ultrasound-guided Radiofrequency Ablation of Celiac Ganglion | Procedure: Ablation of Celiac Ganglion<br>* Endoscopic Ultrasound-guided Radiofrequency Ablation of Celiac Ganglion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain severity-BPI | 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). | From Baseline up to 3 Months | 
| Pain severity-VAS | Change in severity of pain will be assessed using visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst pain possible). | From Baseline up to 3 Months | 
| Pain severity-NRS | Change in severity of pain will be assessed using numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain possible). | From Baseline up to 3 Months | 
| Quality of Life (EORTC PAN26) | 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. | From Baseline up to 3 Months | 
| Quality of Life (EORTC C30) | 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. | From Baseline up to 3 Months | 
| Quality of Life (NFHSI) | 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. | From Baseline up to 3 Months | 
| Concomitant Analgesic/Narcotic Use | 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. | From Baseline up to 3 Months |