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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
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Hemangioma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Definite diagnosis of hepatic hemangioma (more than two imaging evidences: enhanced ultrasound or enhanced CT and MRI), single tumor, 5-15cm in diameter;
  2. The Child-Pugh grade A/B;
  3. The ICG15 20% or less;
  4. The eCOG score was 0;
  5. 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;
  6. The patients refused to receive surgical treatment, but agreed to receive radiofrequency ablation;
  7. There were no other related diseases affecting RFA treatment.

Exclusion Criteria:

  1. Multiple hepatic hemangioma lesions or single lesion < 5cm;
  2. Severe primary organ failure, such as liver, kidney, heart, lung or brain;
  3. Severe bleeding tendency, platelet count < 50 ×10^9/L, or prothrombin time extension > 18s;
  4. 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

    First Posted
    October 11, 2019
    Last Updated
    October 16, 2019
    Sponsor
    Southwest Hospital, China
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    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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