NCT04131153

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Southwest Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatic Hemangioma

Interventions

Type	Name	Description
PROCEDURE	"three-step" radiofrequency ablation	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".
PROCEDURE	radiofrequency ablation	Conventional radiofrequency ablation

Timeline

• Start date: 2013-06-01
• Primary completion: 2018-05-01
• Completion: 2019-08-01
• First posted: 2019-10-18
• Last updated: 2019-10-18