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Microwave Ablation Versus Laparoscopic Hepatectomy for 3-5cm Hepatocellular Carcinoma

Primary Purpose

Overall Survival, Progression-free Survival, Cost

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Microwave Ablation
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overall Survival

Eligibility Criteria

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

Inclusion Criteria: i) age ≥18 years ii) all patients with an initial diagnosis of 3-5cm HCC(within 3 tumors, at least one 3-5cm) by histopathology iii) Child-Pugh class A or B iv) no vascular invasion or distant metastasis v) no other malignant neoplasms within the last 5 years Exclusion Criteria: i) age <18 years ii) Child-Pugh class ≥B iii) vascular invasion or distant metastasis iv) with other malignant neoplasms within the last 5 years

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Microwave Ablation

    Laparoscopic Hepatectomy

    Arm Description

    According to the shape, size and location of each patient's tumor, as well as the adjacent relationship with the surrounding organs, the individual MWA scheme was pre-established. Contrast-enhanced CT (CE-CT) or contrast-enhanced magnetic resonance imaging (CE-MRI) was used to evaluate complete ablation within 3 to 5 days after ablation. If radiography suggested incomplete ablation, supplementary ablation was performed as soon as the patient's condition permitted. A cooled-shaft MW system (KY-2000, Kangyou Medical, China) was used in the procedure.

    The optimal surgical procedure for each patient depends on the characteristics of the tumor. Patients were placed in French position and a laparoscopic-assisted partial hepatectomy was performed under CO2 pneumoperitoneum pressure 12-14 mmHg (1 mmHg =0.133 kPa). In most cases, a 4-well or 5-well method was used under general anesthesia.

    Outcomes

    Primary Outcome Measures

    Overall survival
    OS was defined as death related to any cause and was indexed from the date of ablation or surgery until last contact or death
    Progession-free survival
    DFS was defined as the time interval between first treatment and recurrence or death, whichever occurred earlier.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 3, 2023
    Last Updated
    April 1, 2023
    Sponsor
    Chinese PLA General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05796700
    Brief Title
    Microwave Ablation Versus Laparoscopic Hepatectomy for 3-5cm Hepatocellular Carcinoma
    Official Title
    Microwave Ablation Versus Laparoscopic Hepatectomy for 3-5cm Hepatocellular Carcinoma: a Multicentre Retrospective Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2008 (Actual)
    Primary Completion Date
    October 31, 2019 (Actual)
    Study Completion Date
    December 30, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chinese PLA General Hospital

    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
    As the most common subtype of liver cancer (85% ~ 90%), HCC is highly malignant; thus, one of the crucial issues in HCC management is an effective therapy for tumors at an early stage, which is vital for improving the prognosis of patients. For ≤3cm HCC, ablation has been recommended by international guidelines as a first-line or alternative treatment because of similar survival outcomes and milder liver function injury with liver resection (LR). However, the appropriate treatment options for 3-5cm HCC remain controversial. Thus, none of the international guidelines recommend ablation as a first-line treatment for 3-5cm HCC. In the past few decades, treatment for HCC has tended to be less invasive, have fewer complications, and have higher cost-effectiveness. Compared with LR, laparoscopic Hepatectomy (LH) demonstrates the advancement of minimal invasion. As another minimally invasive technique for HCC, Microwave Ablation (MWA) has the potential to eradicate larger HCCs with larger coagulation areas and is less affected by the heat sink effect caused by vessels around the tumor. Many studies have identified the potential advantages of MWA over other ablation techniques. However, to date, no clinical studies have compared the efficacy of LH and MWA therapies for 3-5cm HCC with periodic progression.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overall Survival, Progression-free Survival, Cost

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    1585 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Microwave Ablation
    Arm Type
    Active Comparator
    Arm Description
    According to the shape, size and location of each patient's tumor, as well as the adjacent relationship with the surrounding organs, the individual MWA scheme was pre-established. Contrast-enhanced CT (CE-CT) or contrast-enhanced magnetic resonance imaging (CE-MRI) was used to evaluate complete ablation within 3 to 5 days after ablation. If radiography suggested incomplete ablation, supplementary ablation was performed as soon as the patient's condition permitted. A cooled-shaft MW system (KY-2000, Kangyou Medical, China) was used in the procedure.
    Arm Title
    Laparoscopic Hepatectomy
    Arm Type
    Active Comparator
    Arm Description
    The optimal surgical procedure for each patient depends on the characteristics of the tumor. Patients were placed in French position and a laparoscopic-assisted partial hepatectomy was performed under CO2 pneumoperitoneum pressure 12-14 mmHg (1 mmHg =0.133 kPa). In most cases, a 4-well or 5-well method was used under general anesthesia.
    Intervention Type
    Procedure
    Intervention Name(s)
    Microwave Ablation
    Other Intervention Name(s)
    Laparoscopic Hepatectomy
    Intervention Description
    Microwave Ablation: A minimally invasive technique for HCC, MWA has the potential to eradicate larger HCCs with larger coagulation areas and is less affected by the heat sink effect caused by vessels around the tumor. Laparoscopic Hepatectomy: The technique has been widely promoted worldwide with technical progress. In patients with cirrhosis, LLR has the potential advantage of reducing the risk of postoperative liver decompensation
    Primary Outcome Measure Information:
    Title
    Overall survival
    Description
    OS was defined as death related to any cause and was indexed from the date of ablation or surgery until last contact or death
    Time Frame
    More than 3 years
    Title
    Progession-free survival
    Description
    DFS was defined as the time interval between first treatment and recurrence or death, whichever occurred earlier.
    Time Frame
    More than 3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: i) age ≥18 years ii) all patients with an initial diagnosis of 3-5cm HCC(within 3 tumors, at least one 3-5cm) by histopathology iii) Child-Pugh class A or B iv) no vascular invasion or distant metastasis v) no other malignant neoplasms within the last 5 years Exclusion Criteria: i) age <18 years ii) Child-Pugh class ≥B iii) vascular invasion or distant metastasis iv) with other malignant neoplasms within the last 5 years

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data can be shared with the consent of the corresponding author.
    IPD Sharing Time Frame
    Data can be shared with the consent of the corresponding author.
    IPD Sharing Access Criteria
    Data can be shared with the consent of the corresponding author.

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    Microwave Ablation Versus Laparoscopic Hepatectomy for 3-5cm Hepatocellular Carcinoma

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