EUS-guided RFA for Pancreatic Neoplasms

  • End date
    May 14, 2023
  • participants needed
  • sponsor
    Chinese University of Hong Kong
Updated on 27 January 2022
fine needle aspiration
pancreatic neuroendocrine tumor
pancreatic neoplasm
breast ductal carcinoma
Accepts healthy volunteers


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.


RFA causes tissue destruction through the application of a high frequency alternating current, generating local temperatures above 60C and leading to coagulative necrosis. The technique has been widely used in many solid organ tumors and has been shown to result in 5-year survival rates comparable to surgery. The technique is currently the standard therapy in hepatocellular carcinoma and colorectal pulmonary metastasis particular in patients that are not suitable for surgery.

This study is a multi-center prospective study involving four high volume international institutions. Consecutive patients suffering from pancreatic neuroendocrine tumors and pancreatic cancers would be recruited. EUS-guided RFA would be performed using a 19-gauge RFA electrode and a generator. The primary outcome would be the overall adverse events rate. Secondary outcomes include mortality, technical success rate, completion ablation rate, 1 & 3 year overall and disease-free survival.

Condition Pancreatic Neoplasms
Treatment EUS-guided RFA
Clinical Study IdentifierNCT03218345
SponsorChinese University of Hong Kong
Last Modified on27 January 2022


Yes No Not Sure

Inclusion Criteria

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 Criteria

Coagulopathy (international normalized ratio >1.3, partial thromboplastin time greater than twice that of control), platelet count <50,000x103/uL
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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