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TIPS Combined With Microwave Ablation in HCC Patients With Refractory Ascites

Primary Purpose

Liver Diseases, Portal Hypertension, Cirrhosis, Liver

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transjugular intrahepatic portosystemic shunt (TIPS)
microwave ablation (MWA)
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Diseases focused on measuring Transjugular intrahepatic portosystemic shunt, refractory ascites, microwave ablation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age between 18-70 years
  2. Diagnosis of HCC based on the European Association for the Study of the Liver
  3. Tumor diameter ≤ 3cm
  4. Refractory ascites based on International Ascites Club: (a) intensive diuretics (spironolactone 400 mg/d combined with furosemide 160 mg/d) and sodium-restricted diet (<90 mmoVd) for at least 1 week have no response; (b) lack of response to diuretic therapy; (c) early recurrence of ascites within 4 weeks; (d) Diuretic-induced complications. The grading of ascites was divided into mild ascites, moderate ascites, and large or gross ascites

Exclusion Criteria:

  1. Congestive heart failure or severe valvular heart failure
  2. Uncontrolled systemic infection or inflammation
  3. Macroscopic vascular invasion or extrahepatic metastasis
  4. Severe pulmonary hypertension
  5. Severe renal insufficiency (except hepatogenic renal insufficiency) (6) rapidly progressive liver failure
  6. Diffuse malignant liver tumor
  7. Contrast agent allergy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    TIPS combined with microwave ablation

    Arm Description

    Outcomes

    Primary Outcome Measures

    overall survival (OS)
    the interval from TIPS to death or lost to follow-up

    Secondary Outcome Measures

    change in Child-Pugh stage
    the liver function stage change from C to B or from B to A
    change in Child-Pugh scores
    decrease of Child-pugh scores
    Incidence of hepatic encephalopathy
    the incidence of hepatic encephalopathy of patients accepting TIPS
    Varices rebleeding rate
    the incidence of varices bleeding of patients accepting TIPS

    Full Information

    First Posted
    November 17, 2020
    Last Updated
    December 17, 2020
    Sponsor
    Sun Yat-sen University
    Collaborators
    Second Affiliated Hospital of Guangzhou Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04640116
    Brief Title
    TIPS Combined With Microwave Ablation in HCC Patients With Refractory Ascites
    Official Title
    Feasibility and Clinical Outcome of TIPS Combined With Subsequent Microwave Ablation in HCC Patients With Refractory Ascites
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2021 (Anticipated)
    Primary Completion Date
    August 30, 2021 (Anticipated)
    Study Completion Date
    June 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sun Yat-sen University
    Collaborators
    Second Affiliated Hospital of Guangzhou Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Transjugular intrahepatic portosystemic shunt (TIPS) could effectively decrease portal hypertension-related complications. This study intends to evaluate the efficacy and safety of TIPS combined with subsequent microwave ablation in HCC patients with refractory ascites.
    Detailed Description
    Hepatocellular carcinoma (HCC) patients with refractory ascites (RA) have a very poor prognosis, and there are no effective treatments recommended by the guidelines. TIPS could downgrade the ascites and improve Child-Pugh scores. TIPS has been a common management model for RA for end-stage liver disease. There is no prospective study evaluating TIPS plus thermal ablation. Thus, the investigators carried out this prospective, single-arm study to find out it.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Diseases, Portal Hypertension, Cirrhosis, Liver, Ascites, Hepatocellular Carcinoma
    Keywords
    Transjugular intrahepatic portosystemic shunt, refractory ascites, microwave ablation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TIPS combined with microwave ablation
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Transjugular intrahepatic portosystemic shunt (TIPS)
    Intervention Description
    A needle punctured the portal vein through the transjugular approach. After a successful puncture, the parenchymal tract was dilated, and covered stents (GORE® VIATORR) were introduced. The specifications of the covered stents were 8 mm × 50 mm, 8 mm × 60 mm, 8 mm × 70 mm, and 8 mm × 80 mm. All of the diameters of the bare stents were 8 mm, and the lengths were 50-80 mm. The portal vein pressure was measured before and after shunt creation. After the insertion of TIPS, all of the patients received a diuretic treatment and a salt-limited diet until the ascites disappeared.
    Intervention Type
    Procedure
    Intervention Name(s)
    microwave ablation (MWA)
    Intervention Description
    MWA: After the patient's ascites disappears, MWA therapy will be performed. A MWA antenna was gradually inserted into the tumor along the predetermined angle under the guidance of Computed Tomography (CT). The whole thermal procedure was conducted under intravenous anesthesia. Vital signs were monitored during the procedure. The settings of the ablation parameters depended upon the manufacturer's recommendation and our experience. Ablation volume was determined by physicians according to liver function, tumor invasion site, and tumor stage. An upper abdominal CT scan was carried out immediately after the procedure to evaluate the ablation area and complications.
    Primary Outcome Measure Information:
    Title
    overall survival (OS)
    Description
    the interval from TIPS to death or lost to follow-up
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    change in Child-Pugh stage
    Description
    the liver function stage change from C to B or from B to A
    Time Frame
    6 months
    Title
    change in Child-Pugh scores
    Description
    decrease of Child-pugh scores
    Time Frame
    6 months
    Title
    Incidence of hepatic encephalopathy
    Description
    the incidence of hepatic encephalopathy of patients accepting TIPS
    Time Frame
    24 months
    Title
    Varices rebleeding rate
    Description
    the incidence of varices bleeding of patients accepting TIPS
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age between 18-70 years Diagnosis of HCC based on the European Association for the Study of the Liver Tumor diameter ≤ 3cm Refractory ascites based on International Ascites Club: (a) intensive diuretics (spironolactone 400 mg/d combined with furosemide 160 mg/d) and sodium-restricted diet (<90 mmoVd) for at least 1 week have no response; (b) lack of response to diuretic therapy; (c) early recurrence of ascites within 4 weeks; (d) Diuretic-induced complications. The grading of ascites was divided into mild ascites, moderate ascites, and large or gross ascites Exclusion Criteria: Congestive heart failure or severe valvular heart failure Uncontrolled systemic infection or inflammation Macroscopic vascular invasion or extrahepatic metastasis Severe pulmonary hypertension Severe renal insufficiency (except hepatogenic renal insufficiency) (6) rapidly progressive liver failure Diffuse malignant liver tumor Contrast agent allergy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qunfnag Zhou, Professor
    Phone
    86 19868000115
    Email
    zhouqun988509@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kangshun Zhu, Professor
    Organizational Affiliation
    Second Affiliated Hospital of Guangzhou Medical University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Fei Gao, Professor
    Organizational Affiliation
    Sun Yat-sen University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    TIPS Combined With Microwave Ablation in HCC Patients With Refractory Ascites

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