Evaluation Of Endoscopic Ultrasound-Guided Radiofrequency Ablation For The Management Of Pancreatic Tumors, ERASE Study

Study Overview

Evaluation of Endoscopic Ultrasound-Guided Radiofrequency Ablation for the Management of Pancreatic Tumors, ERASE Study

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.

PRIMARY OBJECTIVE: I. To assess the efficacy of EUS-RFA of pancreatic cystic neoplasms (PCNs). SECONDARY OBJECTIVES: I. To assess the safety of EUS-guided RFA of PCNs. II. To assess the long-term response to EUS-RFA. OUTLINE: Patients undergo standard of care EUS-fine-needle aspiration (FNA) followed by EUS-RFA on study and may undergo repeat EUS-RFA or EUS-guided chemoablation during surveillance. Patients undergo magnetic resonance imaging (MRI)/magnetic resonance cholangiopancreatography (MRCP), computed tomography (CT), or EUS-FNA at baseline and at follow-up timepoints. After completion of study treatment, patients are followed up every 3-6 months for cysts >= 3 cm or every 6-12 months for cysts < 3 cm for up to 3 years.

Pancreatic Neoplasm

PROCEDURE: Chemical Ablation
PROCEDURE: Computed Tomography
OTHER: Electronic Health Record Review
PROCEDURE: Endoscopic Ultrasound-Guided Fine-Needle Aspiration
PROCEDURE: Endoscopic Ultrasound-Guided Radiofrequency Ablation
PROCEDURE: Magnetic Resonance Cholangiopancreatography
PROCEDURE: Magnetic Resonance Imaging

OSU-22277
NCI-2023-04688 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trial Reporting Program))

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-07-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-03-03
First Submitted that Met QC Criteria 2023-07-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-03-04
First Posted (ACTUAL) 2023-07-27	Results First Posted N/A	Last Verified 2025-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Prevention

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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.	PROCEDURE: Chemical Ablation Undergo EUS-guided chemoablation PROCEDURE: Computed Tomography Undergo CT OTHER: Electronic Health Record Review Ancillary studies PROCEDURE: Endoscopic Ultrasound-Guided Fine-Needle Aspiration Undergo EUS-FNA PROCEDURE: Endoscopic Ultrasound-Guided Radiofrequency Ablation Undergo EUS-RFA PROCEDURE: Magnetic Resonance Cholangiopancreatography Undergo MRI/MRCP PROCEDURE: Magnetic Resonance Imaging Undergo MRI/MRCP

Participant Group/Arm

Intervention/Treatment

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.

PROCEDURE: Chemical Ablation

Undergo EUS-guided chemoablation

PROCEDURE: Computed Tomography

Undergo CT

OTHER: Electronic Health Record Review

Ancillary studies

PROCEDURE: Endoscopic Ultrasound-Guided Fine-Needle Aspiration

Undergo EUS-FNA

PROCEDURE: Endoscopic Ultrasound-Guided Radiofrequency Ablation

Undergo EUS-RFA

PROCEDURE: Magnetic Resonance Cholangiopancreatography

Undergo MRI/MRCP

PROCEDURE: Magnetic Resonance Imaging

Undergo MRI/MRCP

Primary Outcome Measures	Measure Description	Time Frame
Efficacy of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA)	Defined as at least a 50% decrease in the cyst diameter. Other markers of response to EUS-RFA will be evaluated by cross-sectional imaging and EUS: change in the diameter, morphology of cyst - fibrosis, septations, loculations, wall thickness, intracystic or mural nodules; cyst fluid aspiration (biopsy if there is fibrosis): next generation sequencing (NGS) - persistence or absence of mutations (molecular markers), cytology - results can include either: mucin, atypical/suspicious cells, necrotic material, or inflammatory debris, experimental: flow cytometry for immunological markers of antineoplastic response; serological changes: chromogranin A (for cystic-neuroendocrine tumor), and serum cancer antigen (CA) 19-9 (if elevated prior to intervention).	At 1 years after EUS-RFA

Secondary Outcome Measures	Measure Description	Time Frame
Long-term response to EUS-RFA	Defined as at least a 50% decrease in the cyst diameter. Durable response: Continued response with further decrease in cyst diameter beyond the first calendar year. The response will be evaluated by cross-sectional imaging and EUS: change in the diameter, morphology of cyst - fibrosis, septations, loculations, wall thickness, intracystic or mural nodules; cyst fluid aspiration (biopsy if there is fibrosis): NGS - persistence or absence of mutations (molecular markers), cytology - results can include either: mucin, atypical/suspicious cells, necrotic material, or inflammatory debris, experimental: flow cytometry for immunological markers of antineoplastic response; serological changes: chromogranin A (for cystic-neuroendocrine tumor), and serum CA 19-9 (if elevated prior to intervention).	At 2 and 3 years after EUS-RFA
Safety of EUS-guided RFA of pancreatic cystic neoplasms post procedure	Documented using the adverse events in gastrointestinal endoscopy classification for adverse events in gastrointestinal advanced endoscopy. Only grade II or higher degree of complications will be documented since patients are electively admitted after EUS-RFA for overnight observation. If patient has post-procedure acute pancreatitis, document severity based on Revised Atlanta Classification.	Post-procedure (after EUS-RFA)
Safety of EUS-guided RFA of pancreatic cystic neoplasms at one year	Documented using the adverse events in gastrointestinal endoscopy classification for adverse events in gastrointestinal advanced endoscopy. Only grade II or higher degree of complications will be documented since patients are electively admitted after EUS-RFA for overnight observation. If patient has post-procedure acute pancreatitis, document severity based on Revised Atlanta Classification.	at one year after EUS-RFA

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: The Ohio State University Comprehensive Cancer Center

Phone Number: 800-293-5066

Email: OSUCCCClinicaltrials@osumc.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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)

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Somashekar G Krishna, MD, Ohio State University Comprehensive Cancer Center

Publications

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General Publications

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