EUS-guided radiofrequency ablation for small abdominal tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter study of endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA) for solid abdominal neoplasms under 5 cm. Consecutive eligible adult patients at participating high-volume centers will undergo EUS-guided RFA using a 19-gauge electrode and a VIVA RF generator. The primary outcome is overall adverse event rate, with secondary outcomes including mortality, technical success, completion ablation rate, and 1- and 3-year overall and disease-free survival. Key exclusions include coagulopathy, pregnancy, significant liver cirrhosis/portal hypertension, and inability to consent or adhere to follow-up.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Surgery, Prince of Wales Hospital
  Hong Kong, Hong Kong Recruiting

Study contacts

• Principal investigator: Anthony YB Teoh, Professor — Chinese University of Hong Kong
• Study coordinator: Anthony YB Teoh, Professor
• Email: anthonyteoh@surgery.cuhk.edu.hk
• Phone: 26322956

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.