TIPS Combined With Microwave Ablation in HCC Patients With Refractory Ascites

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility and Clinical Outcome of TIPS Combined With Subsequent Microwave Ablation in HCC Patients With Refractory Ascites

Conditions
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Liver Diseases, Portal Hypertension, Cirrhosis, Liver, Ascites, Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: Transjugular intrahepatic portosystemic shunt (TIPS)
* Procedure: microwave ablation (MWA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIPS combined with microwave ablation<br> | Procedure: Transjugular intrahepatic portosystemic shunt (TIPS)<br>* 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.<br>Procedure: microwave ablation (MWA)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) | the interval from TIPS to death or lost to follow-up | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Child-Pugh stage | the liver function stage change from C to B or from B to A | 6 months | 
| change in Child-Pugh scores | decrease of Child-pugh scores | 6 months | 
| Incidence of hepatic encephalopathy | the incidence of hepatic encephalopathy of patients accepting TIPS | 24 months | 
| Varices rebleeding rate | the incidence of varices bleeding of patients accepting TIPS | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transjugular intrahepatic portosystemic shunt, refractory ascites, microwave ablation