Recruiting

Endoscopic Ultrasound-Guided Radiofrequency Ablation

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT05961982

Conditions

Pancreatic Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Chemical Ablation

Computed Tomography

Electronic Health Record Review

Endoscopic Ultrasound-Guided Fine-Needle Aspiration

Endoscopic Ultrasound-Guided Radiofrequency Ablation

Study Details

Brief summary:

This clinical trial evaluates the safety and effectiveness of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) for the management of patients with pancreatic tumors (including cysts) performed during recommended surveillance endoscopic ultrasound examinations. Pancreatic tumors (cysts) can progress to pancreatic cancer at rate of more than 25% per year risk. Pancreatic cancer is a fatal disease that is difficult to diagnose at an early stage, and the five-year survival rate is currently less than 10%. It is projected to be the second leading cause of cancer-related mortality by the year 2030. A procedure known as radiofrequency ablation may help. Radiofrequency ablation is an established way to treat benign and cancerous tumors in the human body. In the last 5 years, radiofrequency ablation has been applied to treat precancerous tumors (including cysts) in the pancreas. This procedure implements a medical technology that destroys tumors in a much less invasive way compared to traditional surgical removal. By delivering a high-frequency alternating current, radiofrequency ablation uses electrical energy and heat to destroy cancer cells. Radiofrequency ablation is being recognized as a management option in patients with high-risk pancreatic tumors (cysts) but are not deemed surgical candidates. While surgical removal offers a chance of cure, pancreatic surgeries have 20-40% morbidity rate (short and long-term complication) and a 1-2% mortality rate in patients who are surgical candidates. Furthermore, radiofrequency ablation can potentially decrease the need for frequent imaging/surveillance of the pancreatic tumor (cyst). In patients with immediate prohibitive, but reversible risks for surgery, radiofrequency ablation of a high-risk tumors (cysts) can potentially prevent further progression of the lesion and bridge the time before the need for surgical resection.

Conditions

Pancreatic Neoplasm

Study ID

NCT05961982

Start date

Apr 24, 2023

Status verified date

Mar, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age > 18 years
  • A diagnosis of a PCN confirmed by EUS-FNA including cyst fluid next generation sequencing (NGS) and/or EUS-guided needle-based confocal laser endomicroscopy (nCLE) and/or EUS- guided through-the-needle biopsy (TTNB)
  • The pancreatic cystic lesion (PCL) measures at least 2 cm in diameter on either CT or MRI/MRCP or EUS and demonstrates concerning worrisome and/or high-risk features as defined by International Consensus Guidelines (2017 revised Fukuoka Guidelines)
  • The patient is not a surgical candidate. Common clinical scenarios include -

  • Cirrhosis of the liver (common clinical scenario)
  • Advanced ( >= 75 years) age (common clinical scenario)
  • Morbid obesity
  • Significant cardiorespiratory comorbidity
  • Patient's choice (patient elects for non-surgical management)
  • Other significant comorbid conditions that impose prohibitive surgical risks
  • Estimated life expectancy of at least 1 year
  • Capable of giving written informed consent or has a legally authorized representative (LAR) to consent for them
  • Women of childbearing potential must have a negative pregnancy test (serum/urine) on the day of treatment. Pregnancy testing is the routine standard of care practice in the endoscopy laboratory for all patients undergoing endoscopy and sedation for endoscopy
  • The patient prefers non-surgical management after consultation with hepato-pancreato-biliary (HPB) surgery
  • The patient is not a surgical candidate and has had prior attempts at ablation of the PCN by EUS-guided injection of chemotherapy (Ohio State University \[OSU\] Institutional Review Board \[IRB\] protocol 2020C0198)

Exclusion Criteria:

  • A diagnosis of a benign or non-neoplastic PCL such as a pseudocyst confirmed by EUS-FNA including cyst fluid NGS and/or EUS-nCLE and/or EUS-TTNB
  • A diagnosis of a malignant PCN confirmed by evidence of adenocarcinoma and/or invasive carcinoma and/or distant metastases
  • Cysts or neuroendocrine tumors (NETS) involving or in close proximity to blood vessels, the biliary tree, or the main pancreatic duct where the zone of ablation is likely to compromise these structures
  • Acute pancreatitis in the preceding 4 weeks prior to date of EUS-RFA
  • Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it unsafe for the patient to participate in the study
  • Any psychiatric disorder making reliable informed consent impossible
  • Pregnancy or breast-feeding
  • Eastern Cooperative Oncology Group (ECOG) performance status 4
  • Contraindication to general anesthesia after review by OSU Preoperative Assessment Clinic (OPAC)
  • Cardiac implantable electrical devices

Study Design

Enrollment

84 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Treatment (EUS-RFA)

Patients undergo standard of care EUS-FNA followed by EUS-RFA on study and may undergo repeat EUS-RFA or EUS-guided chemoablation during surveillance. Patients undergo MRI/MRCP, CT, or EUS-FNA at baseline and at follow-up timepoints.

Interventions

Chemical Ablation

Undergo EUS-guided chemoablation

Computed Tomography

Undergo CT

Electronic Health Record Review

Ancillary studies

Endoscopic Ultrasound-Guided Fine-Needle Aspiration

Undergo EUS-FNA

Endoscopic Ultrasound-Guided Radiofrequency Ablation

Undergo EUS-RFA

Magnetic Resonance Cholangiopancreatography

Undergo MRI/MRCP

Magnetic Resonance Imaging

Undergo MRI/MRCP

Primary outcome measure

  • Efficacy of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) [ Time Frame: At 1 years after EUS-RFA ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Somashekar G. Krishna, MD

614-293-6255Somashekar.Krishna@osumc.edu

Principal Investigator:

Somashekar G. Krishna, MD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-03-23.