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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05535894
• Other study ID #: 2202520088
• Status: Recruiting
• Start date: August 10, 2022
• Est. completion date: May 2024

Study information

• Verified date: August 2022
• Source: West Virginia University
• Contact: Shailendra Singh, MD
• Phone: 3042934123
• Email: shailendra.singh[@]hsc.wvu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Ablation of Celiac Ganglion
Endoscopic Ultrasound-guided Radiofrequency Ablation of Celiac Ganglion

Locations

Country	Name	City	State
United States	Shailendra Singh	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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