EUS-guided RFA for Solid Abdominal Neoplasms
Multi-center Prospective Study on EUS-guided Radiofrequency Ablation for Solid Abdominal Neoplasms.
Chinese University of Hong Kong
30 participants
May 1, 2016
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria9
- 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 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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Interventions
All patients would undergo EUS with a linear array echoendoscope. The location and size of the lesion would be assessed for suitability of treatment. After locating the lesion, the RFA needle would be inserted to the centre of the lesion. RFA would then be initiated and hyperechoic interferences would be observed around the electrode signifying heating of the tissue. The duration of ablation would be according to the size of the lesion.
Locations(1)
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NCT03221335