Evaluation of Endoscopic Ultrasound-Guided Radiofrequency Ablation for the Management of Pancreatic Tumors, ERASE Study (ERASE)
Pancreatic Neoplasm
About this trial
This is an interventional prevention trial for Pancreatic Neoplasm
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 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
Sites / Locations
- Ohio State University Comprehensive Cancer CenterRecruiting
Arms of the Study
Arm 1
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.