EUS-guided RFA for Solid Abdominal Neoplasms

  • End date
    Apr 12, 2024
  • participants needed
  • sponsor
    Chinese University of Hong Kong
Updated on 23 February 2022
radiofrequency ablation
pancreatic cancers


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 solid abdominal 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 cancers.

The aim of the current study is to perform a multi-center prospective study on EUS-guided radiofrequency ablation (RFA) of solid abdominal neoplasms. The hypothesis is that EUS-guided RFA is safe, feasible and effective for treating solid abdominal 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 tumours 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.

The current study would be a multi-center prospective study involving four high volume international institutions. Consecutive patients suffering from solid neoplasms of the liver, stomach and adrenals would be recruited. EUS-guided RFA would be performed using a 19-gauge RFA electrode and a VIVA RF generator (STARmed, Korea). 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 Digestive System Neoplasms
Treatment EUS-guided RFA
Clinical Study IdentifierNCT03221335
SponsorChinese University of Hong Kong
Last Modified on23 February 2022


Yes No Not Sure

Inclusion Criteria

Age 18 years-old or above
Suffering from solid neoplasms of the stomach, liver, kidney or adrenals (<5cm in largest diameter) that is indicated for treatment
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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