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

NCT04131153 | Completed

• 1 other identifier: 20180407
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatic Hemangioma

Outcome Measures

Primary Outcomes (2)

• Duration of Radiofrequency ablation

  Duration of Radiofrequency ablation

  60 minute

• Duration of hospitalization

  Duration of hospitalization

  7 day

Study Arms (2)

Conventional radiofrequency ablation group

OTHER

Conventional radiofrequency ablation procedures

Procedure: radiofrequency ablation

Three-step radiofrequency ablation group

EXPERIMENTAL

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: "three-step" radiofrequency ablation

Interventions

"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".

Three-step radiofrequency ablation group

radiofrequency ablation PROCEDURE

Conventional radiofrequency ablation

Conventional radiofrequency ablation group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 refused to receive surgical treatment, but agreed to receive radiofrequency ablation;
• There were no other related diseases affecting RFA treatment.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Southwest Hospital, China: lead

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 18, 2019
• Study Start: June 1, 2013
• Primary Completion: May 1, 2018
• Study Completion: August 1, 2019
• Last Updated: October 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share