Skip to main content
OpenTrials
Completed

NCT Number: NCT04131153

Percutaneous Ultrasound-guided "Three-step" Radiofrequency Ablation for Giant Hepatic Hemangioma

Hepatic hemangioma is the most common benign tumor of the liver.For huge liver hemangioma, however, it need to use the conventional radiofrequency ablation can increase one-time ablation volume of radiofrequency electrode or enhance ablation power and extend the melting time, not only bring patients suffering discomfort, but easy to damage the adjacent organs, causing serious complications such as hemorrhage, perforation of gastrointestinal tract,acute renal failure .Therefore, the investigators have developed a new, standardized radiofrequency ablation for giant hepatic hemangioma to shorten the duration of treatment, reduce surgical complications and improve the surgical success rate.

The purpose of this study was to evaluate the safety, feasibility and efficacy of the new radiofrequency ablation (" three-step "radiofrequency ablation) in the treatment of giant hepatic hemangioma.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Hepatic hemangioma is the most common benign tumor of the liver, with an incidence of 0.4-20% in the general population.For small and asymptomatic patients with hepatic hemangioma, regular reexamination is necessary without medical intervention.However, patients with giant hepatic hemangioma(diameter ≥ 5cm) may have symptoms such as abdominal pain, indigestion, jaundice, or rapid increase in lesion volume, or even spontaneous rupture and hemorrhage, which require active treatment.Currently, surgical resection is the most effective method for the treatment of hepatic hemangioma, but the incidence and mortality of related complications have been reported as high as 27% and 3% respectively

.Other alternative therapies, such as transcatheter arterial embolization, radiotherapy and steroid therapy, have also been reported for the treatment of hepatic hemangioma, but the efficacy is not satisfactory .

Percutaneous ultrasound-guided radiofrequency ablation is a safe and minimally invasive treatment with reliable efficacy. In recent years, this technique has been successfully applied in the treatment of hepatic hemangioma with a diameter of < 5cm.For huge liver hemangioma, however, need to use the conventional radiofrequency ablation can increase one-time ablation volume of radiofrequency electrode or enhance ablation power and extend the melting time, not only bring patients suffering discomfort, but easy to damage the adjacent organs, causing serious complications such as hemorrhage, perforation of gastrointestinal tract, acute renal failure .Therefore, the investigators have developed a new,standardized radiofrequency ablation for giant hepatic hemangioma to shorten the duration of treatment, reduce surgical complications and improve the surgical success rate.

The purpose of this study was to evaluate the safety, feasibility and efficacy of the new radiofrequency ablation (" three-step "radiofrequency ablation) in the treatment of giant hepatic hemangioma.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Definite diagnosis of hepatic hemangioma (more than two imaging evidences: enhanced ultrasound or enhanced CT and MRI), single tumor, 5-15cm in diameter;
  • The Child-Pugh grade A/B;
  • The ICG15 20% or less;
  • The eCOG score was 0;
  • The patients was persistent hemangioma-related abdominal pain or discomfort, and it has clear exclusion of other gastrointestinal diseases causing upper abdominal pain by gastroscopy;
  • The patients refused to receive surgical treatment, but agreed to receive radiofrequency ablation;
  • There were no other related diseases affecting RFA treatment.

Exclusion criteria

  • Multiple hepatic hemangioma lesions or single lesion < 5cm;
  • Severe primary organ failure, such as liver, kidney, heart, lung or brain;
  • Severe bleeding tendency, platelet count < 50 ×10^9/L, or prothrombin time extension > 18s;
  • Previous treatment of hepatic hemangioma (TACE, steroids, etc.).

Treatment and study plan

"three-step" radiofrequency ablation

Procedure

After destroying the main blood supply of the tumor, extracting the blood in the tumor, reducing the blood flow in the tumor and shrinking the tumor volume, the remaining tumor was then treated with radiofrequency ablation, namely the "three-step" radiofrequency ablation with "one block, two inhalation and three damages".

Radiofrequency ablation

Procedure

Conventional radiofrequency ablation

Primary outcomes

  1. Duration of Radiofrequency ablation

    Time frame: 60 minute

    Duration of Radiofrequency ablation

  2. Duration of hospitalization

    Time frame: 7 day

    Duration of hospitalization

Sponsors and collaborators

Lead sponsor

Southwest Hospital, China

Other

Registry information

Official study title

Percutaneous Ultrasound-guided "Three-step" Radiofrequency Ablation for Giant Hepatic Hemangioma: a Safe, Feasible and Effective New Technology

Acronym: RFA

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Oct 18, 2019
Registry last updated
Oct 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.