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

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.

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