Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID03221335

Multi-center Prospective Study on EUS-guided Radiofrequency Ablation for Solid Abdominal Neoplasms

Led by Chinese University of Hong Kong · Updated on 2026-03-20

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate EUS-guided radiofrequency ablation (RFA) as a treatment for solid abdominal neoplasms, including tumors in the liver, stomach, kidney, and adrenal glands. The study is a multi-center prospective trial involving patients with tumors less than 5 cm in size who are not suitable for surgery. The goal is to assess the safety, feasibility, and effectiveness of this minimally invasive approach for these solid tumors. The treatment involves using a 19-gauge RFA electrode guided by endoscopic ultrasound (EUS) to deliver high-frequency alternating current that heats and destroys tumor tissue through coagulative necrosis. The procedure includes locating the tumor with a linear array echoendoscope, inserting the RFA needle into the lesion, and applying heat based on tumor size. This study is conducted across several high-volume international centers using specialized devices, including the VIVA RF generator. Participants will undergo assessments before and after the procedure, including imaging to evaluate tumor response and monitoring for adverse events within 30 days. Researchers will measure technical success, procedural time, hospital stay, need for re-interventions, and survival rates at 1 and 3 years. Safety is a primary focus, with attention to severe adverse events shortly after treatment. The total follow-up period extends up to 3 years to understand long-term outcomes.

CONDITIONS

Brief Title

EUS-guided RFA for Solid Abdominal Neoplasms

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years-old or above
  • Having solid tumors less than 5 cm in the stomach, liver, kidney, or adrenal glands that need treatment
  • Not suitable for surgery due to one or more of the following: ASA score greater than II, presence of another advanced cancer, or expert opinion
  • Healthy individuals unwilling to have surgical removal
  • Eligible for endoscopic treatment
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Blood clotting problems (INR >1.3, PTT more than twice normal) or low platelet count (<50,000 x10^3/uL)
  • Pregnancy
  • Poor mental condition or inability to understand the study
  • Unwillingness to attend follow-up visits
  • Liver cirrhosis, portal hypertension, or gastric varices

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Single day procedure

Participants undergo EUS-guided radiofrequency ablation (RFA) where a needle electrode is inserted into the tumor to apply localized heat for tissue destruction.

1 visit (in-person)

Post-operative Follow-up

Duration - Up to 3 years

Participants are monitored for adverse events and treatment success with clinical and radiological assessments.

Approximately 6 visits over 3 years

Trial Site Locations

Total: 1 location

1

Department of Surgery, Prince of Wales Hospital

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

A

Anthony YB Teoh, Professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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