EUS-guided RFA for Solid Abdominal Neoplasms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EUS-guided RFA.
- Who it may be relevant to
- Registry conditions: Digestive System Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multi-center Prospective Study on EUS-guided Radiofrequency Ablation for Solid Abdominal Neoplasms.
Overview
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.
Interventions
- Device EUS-guided RFA
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.
Primary outcome measures
- Severe adverse events [Time frame: 30 days]
Secondary outcome measures (6)
- Technical success rates [Time frame: 1 week]
- Procedural times [Time frame: 1 day]
- Hospital stay [Time frame: 30 days]
- Radiological response [Time frame: 1 year]
- Number of re-interventions [Time frame: 1 year]
- Survival [Time frame: 3 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- Department of Surgery, Prince of Wales Hospital — Hong Kong
Identifiers
NCT: NCT03221335 · CRE-2015.707