Clinical trial NCT03221335: EUS-guided RFA for Solid Abdominal Neoplasms
Official title: Multi-center Prospective Study on EUS-guided Radiofrequency Ablation for Solid Abdominal Neoplasms.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Digestive System Neoplasms
Keywords: EUS-guided RFA
liver
stomach
adrenal
kidney tumour
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: RFA causes tissue destruction through the application of a high frequency alternating current, generating local temperatures above 60°C 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.

Eligibility criteria: 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
* 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.

Primary outcomes:
measure: Severe adverse events
timeFrame: 30 days
Secondary outcomes:
measure: Technical success rates
timeFrame: 1 week
measure: Procedural times
timeFrame: 1 day
measure: Hospital stay
timeFrame: 30 days
measure: Radiological response
timeFrame: 1 year
measure: Number of re-interventions
timeFrame: 1 year
measure: Survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Surgery, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Anthony YB Teoh, Professor
role: PRINCIPAL_INVESTIGATOR
References: