EUS-guided RFA for Pancreatic Neoplasms
Recruiting · NCT03218345 · Interventional (participants receive a specific treatment) · Lead sponsor: Chinese University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
- 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.
Where it is running
1 location listed.
- Department of Surgery, Prince of Wales Hospital - Hong Kong, Hong Kong