Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Small Benign Pancreatic Tumors
Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Small Benign Pancreatic Tumors
Incidental pancreatic solid or cystic lesions are diagnosed with increased frequency due to
 the widespread use of abdominal cross-sectional imaging to investigate unrelated symptoms.
 Lesions such as neuroendocrine tumors (NET), mucinous cystadenomas and intraductal papillary
 mucinous neoplasms (IPMNs) have the potential of malignant transformation. The standard
 treatment of solid or cystic pancreatic lesions with malignant potential has been surgical
 resection, with lesions in the pancreatic head requiring a Whipple resection whereas
 pancreatic tail lesions are treated with distal pancreatectomy. Both types of resection carry
 significant morbidity and mortality. The study would like to outline the feasibility, safety,
 adverse events and early results of endoscopic ultrasound (EUS) - radiofrequency ablation
 (RFA) in pancreatic neoplasms.
The intervention described was radiofrequency ablation which was applied with an innovative
 monopolar radiofrequency probe (1.2 mm Habib EUS-RFA catheter) placed through a 19 or 22
 gauge fine needle aspiration (FNA) needle once FNA was performed in patients with a tumor in
 the head of the pancreas. The device had been certificated by the European Union (EU) and
 received Food and Drug Administration (FDA) approval in 2015. The endoscopic ultrasound (EUS)
 - radiofrequency ablation (RFA) is a 1 Fr wire with a working length of 190 cm, which can be
 inserted through the biopsy channel of a EUS. RF power is applied to the electrode at the end
 of the wire to coagulate tissue in the liver and pancreas. In this study, the investigators
 will enroll 20 patients to receiving EUS-RFA of pancreatic neoplasms with the monopolar RF
 probe. The follow-up period will be one year with regular monitoring. Our primary endpoint
 will be to evaluate pancreatic tumor ablation effect, Secondary objectives will be to
 evaluate the mortality and morbidity.
Inclusion Criteria:

 -  Patients must meet all of the following inclusion criteria to be eligible for this
 study:

 1. Cystic neoplasms in pancreatic parenchyma or outer portion of the pancreas are
 defined by radiologists who evaluate the images more than twice in three months.
 The size of benign cystic neoplasm is between 0.5-3 cm. Or surgical specialist
 physician considers the benign tumor that larger than 3 cm is not suitable for
 surgery or patients unwilling to accept surgery.

 2. Normal physical condition. Eastern Cooperative Oncology Group (ECOG) score of 0-2
 and American Society of Anaesthesiologists (ASA) score ≤ 3.

 3. Normal blood coagulation. Platelet count ≥ 100 K/Μl. Prothrombin time (PT)-
 international normalized ratio (INR) ≦ 1.5.

 4. Prior Informed Consent Form.

 5. Life expectancy of at least 3 months.

 Exclusion Criteria:

 -  Patients presenting with any of the following will not be enrolled into this study:

 1. Women who are pregnant or women of child-bearing potential who are not using an
 acceptable method of contraception.

 2. To participate in any related tumor therapy clinical trials within thirty days
 prior to surgery.

 3. Any active metal implanted device (eg Pacemaker)

 4. Patients who have other malignancies and have not been cured within five years.

 5. Patients with resectable pancreatic cancer.

 6. Simple pancreatic cysts (including pseudocysts) or serous cystadenoma.

 7. Cystic part of the tumor is close to blood vessels or bile duct (<0.5 cm) that
 might injury the related structure.

 8. Cystic pancreatic tumors originate from or associate the pancreatic ducts.

 9. Have acute pancreatitis in the past four weeks

 10. Known history of human immunodeficiency virus (HIV) infection

 11. Have cardiovascular diseases (such as acute myocardial infarction, or stroke)
 within the last three months

 12. Moderate to severe renal dysfunction (Estimated Glomerular Filtration Rate (eGFR)
 <60)

 13. Have any serious or poor control of systemic disease that are not suitable for
 this test and followup