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

Recruiting

• Conditions: Pancreatic Cancer
• Interventions: Procedure: Ablation of Celiac Ganglion

• Registration Number: NCT05535894
• Lead Sponsor: West Virginia University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-10
• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Unresectable Pancreatic Cancer	Ablation of Celiac Ganglion	Endoscopic Ultrasound-guided Radiofrequency Ablation of Celiac Ganglion

Primary Outcome Measures

Name	Time	Method
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.
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-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).
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).
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.
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.

Trial Locations

Locations (1)

Shailendra Singh; 🇺🇸 Morgantown, West Virginia, United States