Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Small Benign Pancreatic Tumors (NCT02882503) | Clinical Trial Compass
WithdrawnNot Applicable
Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Small Benign Pancreatic Tumors
Taiwan0Started 2016-06
Plain-language summary
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.
Who can participate
Age range20 Years β 75 Years
SexALL
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Inclusion criteria
β. 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.
β. Normal physical condition. Eastern Cooperative Oncology Group (ECOG) score of 0-2 and American Society of Anaesthesiologists (ASA) score β€ 3.
β. Normal blood coagulation. Platelet count β₯ 100 K/Ξl. Prothrombin time (PT)- international normalized ratio (INR) β¦ 1.5.
β. Prior Informed Consent Form.
β. Life expectancy of at least 3 months.
Exclusion criteria
β. Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception.
β. To participate in any related tumor therapy clinical trials within thirty days prior to surgery.
β. Any active metal implanted device (eg Pacemaker)