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Endoscopic Radiofrequency Ablation

Sponsor:

West Virginia University

Code:

NCT05535894

Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ablation of Celiac Ganglion

Study Details

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

Study ID

NCT05535894

Start date

Aug 10, 2022

Status verified date

Mar, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Interventions and Outcome Measures

Arms

Unresectable Pancreatic Cancer

Endoscopic Ultrasound-guided Radiofrequency Ablation of Celiac Ganglion

Interventions

Ablation of Celiac Ganglion

Endoscopic Ultrasound-guided Radiofrequency Ablation of Celiac Ganglion

Primary outcome measure

  • Pain severity-BPI [ Time Frame: From Baseline up to 3 Months ]
  • Pain severity-VAS [ Time Frame: From Baseline up to 3 Months ]
  • Pain severity-NRS [ Time Frame: From Baseline up to 3 Months ]
  • Quality of Life (EORTC PAN26) [ Time Frame: From Baseline up to 3 Months ]
  • Quality of Life (EORTC C30) [ Time Frame: From Baseline up to 3 Months ]
  • Quality of Life (NFHSI) [ Time Frame: From Baseline up to 3 Months ]
  • Concomitant Analgesic/Narcotic Use [ Time Frame: From Baseline up to 3 Months ]

Central Contacts and Locations

Central contacts

Locations

Shailendra Singh

Recruiting

Morgantown, West Virginia, United States, 26508

Contacts

Principal Investigator:

Shailendra Singh, MD

More Information

Sponsor

West Virginia University

Last update posted

Mar 11, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-28. This information was provided to ClinicalTrials.gov by West Virginia University on 2025-03-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.