RecruitingNot ApplicableNCT03218345

EUS-guided RFA for Pancreatic Neoplasms

Multi-center Prospective Study on EUS-guided Radiofrequency Ablation for Solid Pancreatic Neoplasms

Sponsor

Chinese University of Hong Kong

Enrollment

30 participants

Start Date

Aug 1, 2016

Study Type

INTERVENTIONAL

Conditions

Pancreatic Neoplasms

Summary

Radiofrequency ablation has been used for treatment of solid neoplasms of the liver, lung, kidney and adrenal. Recently, EUS-guided RFA has become available and the device allows EUS-guided treatment of pancreatic neoplasms. The procedure has been shown to be feasible in the porcine pancreas and was used to treat small groups of patients that are not suitable for surgery suffering from pancreatic neoplasms. The aim of the current study is to perform a multi-center prospective study on EUS-guided radiofrequency ablation (RFA) of solid pancreatic neoplasms. The hypothesis is that EUS-guided RFA is safe, feasible and effective for treating solid pancreatic neoplasms.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

Age 18 years-old or above
Suffering from pancreatic neuroendocrine tumor or pancreatic ductal carcinoma (<5cm in largest diameter) that was confirmed by fine needle aspiration cytology
Unsuitable for surgery, due to one (or more) of the following items:
ASA score > II*
An alternative advanced malignancy
Unsuitable for surgery upon expert's opinion for any other reason
Healthy individuals who are not keen for surgical resection
Eligible for endoscopic intervention
Written informed consent

Exclusion Criteria5

Coagulopathy (international normalized ratio >1.3, partial thromboplastin time greater than twice that of control), platelet count <50,000x103/uL
Pregnancy
Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study
Patients unwilling to undergo follow-up assessments
Patients with liver cirrhosis, portal hypertension and/or gastric varices.

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