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

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

NCT ID: NCT05961982

Condition: Pancreatic Neoplasm

Conditions: Official terms:
Pancreatic Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Chemical Ablation
Description: Undergo EUS-guided chemoablation
Arm group label: Treatment (EUS-RFA)

Other name: ABLATION, CHEMICAL

Intervention type: Procedure
Intervention name: Computed Tomography
Description: Undergo CT
Arm group label: Treatment (EUS-RFA)

Other name: CAT

Other name: CAT Scan

Other name: Computed Axial Tomography

Other name: Computerized Axial Tomography

Other name: Computerized axial tomography (procedure)

Other name: Computerized Tomography

Other name: CT

Other name: CT Scan

Other name: tomography

Intervention type: Other
Intervention name: Electronic Health Record Review
Description: Ancillary studies
Arm group label: Treatment (EUS-RFA)

Intervention type: Procedure
Intervention name: Endoscopic Ultrasound-Guided Fine-Needle Aspiration
Description: Undergo EUS-FNA
Arm group label: Treatment (EUS-RFA)

Other name: endoscopic ultrasound-guided fine needle aspiration

Other name: EUS-FNA

Intervention type: Procedure
Intervention name: Endoscopic Ultrasound-Guided Radiofrequency Ablation
Description: Undergo EUS-RFA
Arm group label: Treatment (EUS-RFA)

Other name: EUS-RFA

Intervention type: Procedure
Intervention name: Magnetic Resonance Cholangiopancreatography
Description: Undergo MRI/MRCP
Arm group label: Treatment (EUS-RFA)

Other name: MRCP

Intervention type: Procedure
Intervention name: Magnetic Resonance Imaging
Description: Undergo MRI/MRCP
Arm group label: Treatment (EUS-RFA)

Other name: Magnetic Resonance

Other name: Magnetic resonance imaging (procedure)

Other name: Magnetic Resonance Imaging Scan

Other name: Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance

Other name: MR

Other name: MR Imaging

Other name: MRI

Other name: MRI Scan

Other name: NMR Imaging

Other name: NMRI

Other name: Nuclear Magnetic Resonance Imaging

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Ohio State University Comprehensive Cancer Center

Address:
City: Columbus
Zip: 43210
Country: United States

Status: Recruiting

Contact:
Last name: Somashekar G. Krishna, MD

Phone: 614-293-6255
Email: Somashekar.Krishna@osumc.edu

Investigator:
Last name: Somashekar G. Krishna, MD
Email: Principal Investigator

Start date: April 24, 2023

Completion date: December 31, 2025

Lead sponsor:
Agency: Ohio State University Comprehensive Cancer Center
Agency class: Other

Source: Ohio State University Comprehensive Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05961982
http://cancer.osu.edu