Endoscopic Radiofrequency Ablation Of Celiac Ganglion For Pain Management And Improvement Of Quality Of Life In Patients With Unresectable Pancreatic Cancer

Study Overview

Endoscopic 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.

N/A

Pancreatic Cancer

PROCEDURE: Ablation of Celiac Ganglion

2202520088

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-09-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-03-10
First Submitted that Met QC Criteria 2022-09-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-03-25
First Posted (ACTUAL) 2022-09-10	Results First Posted N/A	Last Verified 2025-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/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

Participant Group/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

Primary Outcome Measures	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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Shailendra Singh, MD

Phone Number: 3042934123

Email: shailendra.singh@hsc.wvu.edu

Study Contact Backup

Name: Arunkumar Krishnan

Phone Number: 3042937495

Email: arunkumar.krishnan@hsc.wvu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Shailendra Singh, MD, West Virginia University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record