A randomized controlled trial on radiofrequency ablation using variable and fixed electrodes for the treatment of malignant hepatic tumors

A randomized controlled trial on radiofrequency ablation using variable and fixed electrodes for the treatment of malignant hepatic tumors - A randomized controlled trial on radiofrequency ablation using variable and fixed electrodes for the treatment of malignant hepatic tumors

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032072

Enrollment

210

Registered

2018-04-03

Start date

2017-05-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malignant hepatic tumors

Interventions

Adjustable tip electrode RFA system fixed tip electrode RFA system

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (i) ineligible for surgical resection, liver transplantation or patient refusal for surgery (ii) three or fewer tumors of 3 cm or smaller in diameter, or a single tumor of 5 cm or smaller in diameter (iii) no extrahepatic metastasis nor vascular invasion

Exclusion criteria

Exclusion criteria: (i) tumor not visualized by ultrasonography or not accessible percutaneously (ii) total bilirubin level of 3.0 mg/dl or higher (iii) platelet count of less than 50x10 9/l or prothrombin activity of less than 50% (iv) refractory ascites (v) enterobiliary reflux

Design outcomes

Primary

Measure	Time frame
The primary endpoints are the incidence of adverse events and the short-term treatment response based on contrast-CT using the modified RECIST criteria following one session of radiofrequency ablation.	—

Countries

Japan

Contacts

Public ContactSHUICHIRO SHIINA

Juntendo University Department of Gastroenterology

ivo@juntendo.ac.jp03-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026