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

NCT ID: NCT05961982

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-24
• Study Completion Date: 2027-12-31

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.

Detailed Description

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.

Conditions

Pancreatic Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Chemical Ablation

Intervention Type: PROCEDURE

Undergo EUS-guided chemoablation

Computed Tomography

Intervention Type: PROCEDURE

Undergo CT

Electronic Health Record Review

Intervention Type: OTHER

Ancillary studies

Endoscopic Ultrasound-Guided Fine-Needle Aspiration

Intervention Type: PROCEDURE

Undergo EUS-FNA

Endoscopic Ultrasound-Guided Radiofrequency Ablation

Intervention Type: PROCEDURE

Undergo EUS-RFA

Magnetic Resonance Cholangiopancreatography

Intervention Type: PROCEDURE

Undergo MRI/MRCP

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo MRI/MRCP

Interventions

Chemical Ablation

Undergo EUS-guided chemoablation

Intervention Type: PROCEDURE

Computed Tomography

Undergo CT

Intervention Type: PROCEDURE

Electronic Health Record Review

Ancillary studies

Intervention Type: OTHER

Endoscopic Ultrasound-Guided Fine-Needle Aspiration

Undergo EUS-FNA

Intervention Type: PROCEDURE

Endoscopic Ultrasound-Guided Radiofrequency Ablation

Undergo EUS-RFA

Intervention Type: PROCEDURE

Magnetic Resonance Cholangiopancreatography

Undergo MRI/MRCP

Intervention Type: PROCEDURE

Magnetic Resonance Imaging

Undergo MRI/MRCP

Intervention Type: PROCEDURE

Other Intervention Names

ABLATION, CHEMICAL; CAT; CAT Scan; Computed Axial Tomography; Computerized Axial Tomography; Computerized axial tomography (procedure); Computerized Tomography; CT; CT Scan; tomography; endoscopic ultrasound-guided fine needle aspiration; EUS-FNA; EUS-RFA; MRCP; Magnetic Resonance; Magnetic resonance imaging (procedure); Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR; MR Imaging; MRI; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Somashekar Krishna

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Somashekar G Krishna, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

The Ohio State University Comprehensive Cancer Center

Role: CONTACT

OSUCCCClinicaltrials@osumc.edu

800-293-5066

Facility Contacts

Somashekar G. Krishna, MD

Role: primary

Somashekar.Krishna@osumc.edu

614-293-6255

Related Links

http://cancer.osu.edu

The Jamesline

Other Identifiers

NCI-2023-04688

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-22277

Identifier Type: -

Identifier Source: org_study_id

NCT05916846

Identifier Type: -

Identifier Source: nct_alias