Endoscopic Ultrasound-guided Radiofrequency Ablation of Pancreatic Cysts (ERASE) (ERASE)

A single-center study to determine the safety and efficacy of EUS-guided radiofrequency ablation (RFA) of pancreatic cystic neoplasms (PCNs). Patients will be recruited sequentially to undergo RFA followed by standard surveillance. The study will recruit patients with pancreatic cystic lesions (PCLs) who are at high risk for surgical resection. Patients enrolled in the study will be followed up for 3-years after EUS-guided RFA.

This is a single-center prospective study evaluating EUS-guided RFA of PCNs (Figure 1). The study plans to enroll patients over a 3-year duration. Patients with a definitive diagnosis of a PCN and with prohibitive risks for surgery will be recruited sequentially to undergo EUS-guided RFA followed by standard of care surveillance. The following assessments will be completed. Pre-recruitment radiological and EUS investigations should be performed within 3-6 months of planned enrollment and treatment. The pre-recruitment evaluation is part of the routine standard of care (SOC) assessment of PCNs. Pre-treatment/ Baseline These are standard of care practices for management of PCNs defined by International Consensus Guidelines (ICG) and American College of Gastroenterology PCL Guidelines. Pre-treatment requirements: 1. MRI/MRCP (month -6 to day 0). Imaging will not be performed if already available as part of standard of practice in managing PCLs 2. Pancreatic protocol CT abdomen (month -6 to day 0) (if a patient cannot undergo MRI/MRCP) 3. Physical examination (including ECOG (Eastern Cooperative Oncology Group) performance status) 4. Laboratory: Complete Blood Count (CBC), Basic Metabolic Panel (BMP), Liver Function Tests (LFTs), Prothrombin Time (PT) Test & International Normalised Ratio (INR) blood test, serum CA19-9 (cancer antigen 19-9), serum amylase, lipase, Chromogranin A (for cystic-NET). Laboratory tests will not be performed if already available as part of the standard of practice in managing PCLs and standard of care prior to routine EUS-FNA (fine needle aspiration). 5. EUS with FNA (as per ICG) with at least one of the following advanced diagnostics - EUS-nCLE (needle-guided confocal laser endomicroscopy) or cyst fluid analysis by NGS (Next-generation sequencing). 6. Experimental arm: Cyst fluid will also be sent for pre-treatment flow cytometry for immunological markers of antineoplastic response (baseline) Treatment (Day 0): Physical examination Informed consent Pregnancy tests when indicated, will not be performed if already available as part of the standard of practice in managing PCLs and standard of care prior to routine EUS-FNA. Administration of pre-procedure prophylaxis against post-EUS-RFA pancreatitis. This is the standard prophylaxis used to prevent pancreatitis during ERCP (Endoscopic retrograde cholangiopancreatography) procedures. This will involve Ringers Lactate as choice of IV fluid, per rectal indomethacin administered during the procedure, and only clear liquid diet is permitted post-procedure (till next morning). One dose IV quinolone antibiotic (or equivalent if patient has allergy to quinolones) Anesthesia: The standard of practice anesthesia required for any EUS procedure will be applied during the procedure. Anesthesia can be either Monitored Anesthesia Care (MAC) or general. As per standard practice, all patients referred for EUS will undergo nursing triage. If and when indicated, patients will be referred to OSU Preoperative Assessment Clinic (OPAC) for review by anesthesia prior to the procedure. EUS-FNA (if sufficient send for cyst fluid analysis as per SOC) and EUS-RFA of PCN Inpatient admission for overnight observation Apply AGREE classification for adverse events, document only Grade II and above since patients are admitted for observation If patient has post-procedure acute pancreatitis, document severity based on Revised Atlanta Classification Post-procedure day # 1: 1. Symptom and adverse event monitoring - AGREE classification and Revised Atlanta Classification (Appendix 3) in patients with acute pancreatitis 2. Physical examination 3. Laboratory: CBC, BMP, LFTs, Lipase on post-procedure day # 1 Follow-up & response assessment These are standard of care practices for the management of PCNs defined by International Consensus Guidelines (ICG)3 and/or American College of Gastroenterology Guidelines.21 For cyst ≥ 3 cm, follow-up is every 3-6 months 1. Physical examination (including ECOG (performance status) 2. Imaging with MRI/MRCP or CT abdomen (pancreatic protocol) For cysts < 3 cm, follow-up is every 6-12 months Physical examination (including ECOG performance status) Imaging with MRI/MRCP or CT abdomen (pancreatic protocol) For all cysts 1. Alternate MRI/MRCP (or CT imaging) with EUS every 6 months to 1 year (SOC, ICG cyst guidelines) Total duration of follow-up Indefinitely as per standard of care in patients with pancreatic cysts (SOC, ICG cyst guidelines) 3 calendar years of documentation for study purposes

Single arm study. EUS-guided intervention with radiofrequency ablation of pancreatic cystic lesions. Primary population of interest: Branch duct IPMN (intraductal papillary mucinous neoplasm) with high-risk for surgical intervention. The intervention is performed using an FDA-cleared device (EUS-RFA probe).

EUS-RFA is performed with an 19 Gauge RFA needle (STARMed/TaeWoong Medical USA) applying up to 30 Watt (W) current with Continuance Mode setting. RFA confirmation is confirmed endoscopically via EUS (white bubbles on EUS imaging) and impedance monitoring on the VIVA™ Combo System. Impedance has a maximum value up 800 Ohms. Sequential doses of electrical energy at 10W-30W are applied to ablate the PCN.

1) Significant ablation: Defined as at least a 50% decrease in the cyst diameter measured in millimeters (mm). i) Cross-sectional imaging and EUS (1) Change in the diameter, measured in millimeters (mm) AND/OR 2) Resolution of pathogenic mutations ii) Cyst fluid aspiration (1) NGS - Persistence or absence of mutations (molecular markers)

Assess the safety of EUS-guided RFA of PCNs. Documented using the AGREE classification, Grade 2 or above, for adverse events in gastrointestinal advanced endoscopy. Presence or absence of post-procedure acute pancreatitis, document severity based on Revised Atlanta Classification.

Time point 1: Immediately post-procedure (after EUS-RFA) in endoscopy unit up to 24 hours after procedure; Time point 2: At one calendar year after EUS-RFA

Durable response: Continued response with further decrease in cyst diameter beyond the first calendar year. AND/OR Significant ablation: Defined as at least a 50% decrease in the cyst diameter measured in millimeters (mm). i) Cross-sectional imaging and EUS (1) Change in the diameter, measured in millimeters (mm) AND/OR ) Resolution of pathogenic mutations ii) Cyst fluid aspiration (1) NGS - Persistence or absence of mutations (molecular markers)

Inclusion Criteria: Age >18 years. A diagnosis of a PCN confirmed by EUS-FNA including cyst fluid NGS and/or EUS-nCLE and/or EUS-TTNB (through the needle biopsy). The 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 after consultation with Hepato-Pancreato-Biliary (HPB) surgery and/or review in the pancreatic multi-disciplinary tumor board conference. Common clinical scenarios include - Cirrhosis of the liver (common clinical scenario) Advanced 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 (OSU 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 NETS (neuroendocrine tumors) involving or in close proximity to blood vessels or the biliary tree where the zone of ablation is likely to compromise these structures. PCNs such as IPMNs involving the main pancreatic duct as in mixed-IPMN lesions. 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. ECOG performance status 4. Contraindication to general anesthesia after review by OSU Preoperative Assessment Clinic (OPAC) Cardiac Implantable Electrical Devices

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