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

NCT05535894 | Completed

• 1 other identifier: 2202520088
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

Unresectable Pancreatic Cancer

Endoscopic Ultrasound-guided Radiofrequency Ablation of Celiac Ganglion

Procedure: Ablation of Celiac Ganglion

Interventions

Ablation of Celiac Ganglion PROCEDURE

Endoscopic Ultrasound-guided Radiofrequency Ablation of Celiac Ganglion

Unresectable Pancreatic Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

Shailendra Singh

Morgantown, West Virginia, 26508, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Shailendra Singh, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor & Director, Bariatric Endoscopy

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 10, 2022
• Study Start: August 10, 2022
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: April 28, 2026

Record last verified: 2025-03

Locations

US (1)