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

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Procedure: Ablation of Celiac Ganglion

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26508
      • Shailendra Singh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced pancreatic cancer who are deemed as non-surgical candidates

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

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

Collaborators and Investigators

• Sponsor: West Virginia University
• Investigators: Principal Investigator: Shailendra Singh, MD, West Virginia University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Actual): August 30, 2025
• Study Completion (Actual): August 30, 2025

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 2202520088

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No