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Completed

NCT Number: NCT05535894

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shailendra Singh

Morgantown, West Virginia, 26508, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ablation of Celiac Ganglion

Procedure

Endoscopic Ultrasound-guided Radiofrequency Ablation of Celiac Ganglion

Primary outcomes

  1. Pain severity-BPI

    Time frame: 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).

  2. Pain severity-VAS

    Time frame: 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).

  3. Pain severity-NRS

    Time frame: 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).

  4. Quality of Life (EORTC PAN26)

    Time frame: 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.

  5. Quality of Life (EORTC C30)

    Time frame: 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.

  6. Quality of Life (NFHSI)

    Time frame: 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.

  7. Concomitant Analgesic/Narcotic Use

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 10, 2022
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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