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.
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 -
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
Single group
Chemical Ablation
Procedure/SurgeryUndergo EUS-guided chemoablation
Computed Tomography
Procedure/SurgeryUndergo CT
Electronic Health Record Review
Other interventionAncillary studies
Endoscopic Ultrasound-Guided Fine-Needle Aspiration
Procedure/SurgeryUndergo EUS-FNA
Endoscopic Ultrasound-Guided Radiofrequency Ablation
Procedure/SurgeryUndergo EUS-RFA
Magnetic Resonance Cholangiopancreatography
Procedure/SurgeryUndergo MRI/MRCP
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI/MRCP
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).
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).
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.
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.
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