Percutaneous Ultrasound-guided "Three-step" Radiofrequency Ablation for Giant Hepatic Hemangioma (RFA)
Primary Purpose
Hepatic Hemangioma
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
"three-step" radiofrequency ablation
radiofrequency ablation
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Hemangioma
Eligibility Criteria
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.).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Conventional radiofrequency ablation group
Three-step radiofrequency ablation group
Arm Description
Conventional radiofrequency ablation procedures
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".
Outcomes
Primary Outcome Measures
Duration of Radiofrequency ablation
Duration of Radiofrequency ablation
Duration of hospitalization
Duration of hospitalization
Secondary Outcome Measures
Full Information
NCT ID
NCT04131153
First Posted
October 11, 2019
Last Updated
October 16, 2019
Sponsor
Southwest Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT04131153
Brief Title
Percutaneous Ultrasound-guided "Three-step" Radiofrequency Ablation for Giant Hepatic Hemangioma
Acronym
RFA
Official Title
Percutaneous Ultrasound-guided "Three-step" Radiofrequency Ablation for Giant Hepatic Hemangioma: a Safe, Feasible and Effective New Technology
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2013 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
August 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Hemangioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional radiofrequency ablation group
Arm Type
Other
Arm Description
Conventional radiofrequency ablation procedures
Arm Title
Three-step radiofrequency ablation group
Arm Type
Experimental
Arm Description
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".
Intervention Type
Procedure
Intervention Name(s)
"three-step" radiofrequency ablation
Intervention Description
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".
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation
Intervention Description
Conventional radiofrequency ablation
Primary Outcome Measure Information:
Title
Duration of Radiofrequency ablation
Description
Duration of Radiofrequency ablation
Time Frame
60 minute
Title
Duration of hospitalization
Description
Duration of hospitalization
Time Frame
7 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.).
12. IPD Sharing Statement
Plan to Share IPD
No
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Percutaneous Ultrasound-guided "Three-step" Radiofrequency Ablation for Giant Hepatic Hemangioma
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