EUS-guided radiofrequency ablation for small abdominal tumors
Multi-center Prospective Study on EUS-guided Radiofrequency Ablation for Solid Abdominal Neoplasms.
NA · Chinese University of Hong Kong · NCT03221335
This trial will try endoscopic ultrasound-guided radiofrequency ablation to treat small solid tumors (under 5 cm) in the liver, stomach, kidney, or adrenal glands in adults who are not candidates for surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT03221335 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with solid tumors of the liver, stomach, kidney, or adrenal under 5 cm who are unsuitable for surgical resection or decline surgery and are eligible for endoscopic intervention.
Not a fit: Patients with coagulopathy, significant liver cirrhosis or portal hypertension, pregnancy, or inability/unwillingness to consent or follow up are unlikely to be candidates or to receive benefit.
Why it matters
Potential benefit: If successful, this approach could provide a minimally invasive option to destroy small abdominal tumors for patients who cannot have surgery.
How similar studies have performed: EUS-guided RFA has shown feasibility in animal models and small human series (including pancreatic cases), but large multicenter outcome data are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hong Kong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Digestive System Neoplasms, EUS-guided RFA, liver, stomach, adrenal, kidney tumour