Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Small Benign Pancreatic Tumors

Neuroendocrine Tumors Clinical Trial

Official title: A Prospective Clinical Study of Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Small Benign Pancreatic Tumors

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Cystic Neoplasms
• Neuroendocrine Tumors
• Pancreatic Neoplasms

• NCT number: NCT02882503
• Study type: Interventional
• Source: National Taiwan University Hospital
• Status: Withdrawn
• Phase: N/A
• Start date: June 2016
• Completion date: May 7, 2019