Pancreatic CancerNCT05535894
Endoscopic Radiofrequency Ablation of Celiac Ganglion for Pain Management and Improvement of Quality of Life in Patients With Unresectable Pancreatic Cancer
An observational study of Pancreatic Cancer, run by West Virginia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Ablation of Celiac Ganglion
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2022to 30 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced pancreatic cancer who are deemed as non-surgical candidates
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Ablation of Celiac Ganglion
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation of Celiac GanglionProcedure or surgery
Endoscopic Ultrasound-guided Radiofrequency Ablation of Celiac Ganglion
| Study group | Role | What they receive |
|---|---|---|
| Unresectable Pancreatic Cancer | Endoscopic Ultrasound-guided Radiofrequency Ablation of Celiac Ganglion Receives: Procedure: Ablation of Celiac Ganglion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline up to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start10 Aug 2022
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shailendra Singh, West Virginia University
- Investigators
- Shailendra Singh, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535894
- Sponsor's protocol ID
- 2202520088
- Status last verified
- Mar 2025
- First submitted
- 7 Sep 2022
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05535894
- Acronym / sponsor ID
- 2202520088
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unresectable Pancreatic Cancer | – | Procedure: Ablation of Celiac GanglionEndoscopic Ultrasound-guided Radiofrequency Ablation of Celiac Ganglion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced pancreatic cancer who are deemed as non-surgical candidates
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablation of Celiac GanglionEndoscopic Ultrasound-guided Radiofrequency Ablation of Celiac Ganglion | Procedure or surgery | Unresectable Pancreatic Cancer |
Primary outcome
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).
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).
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).
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shailendra Singh, MD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity-BPI (time frame: From Baseline up to 3 Months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.