TIPS Combined With Microwave Ablation in HCC Patients With Refractory Ascites

Sponsor

Sun Yat-sen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04640116

Collaborator

Second Affiliated Hospital of Guangzhou Medical University (Other)

Enrollment

Arm

28.9

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Diseases Portal Hypertension Cirrhosis, Liver Ascites Hepatocellular Carcinoma	Procedure: Transjugular intrahepatic portosystemic shunt (TIPS) Procedure: microwave ablation (MWA)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Aug 30, 2021

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TIPS combined with microwave ablation	Procedure: Transjugular intrahepatic portosystemic shunt (TIPS) 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. Procedure: microwave ablation (MWA) 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.

Arm

Intervention/Treatment

Experimental: TIPS combined with microwave ablation

Procedure: Transjugular intrahepatic portosystemic shunt (TIPS)

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.

Procedure: microwave ablation (MWA)

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.

Outcome Measures

Primary Outcome Measures

overall survival (OS) [24 months]
the interval from TIPS to death or lost to follow-up

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sun Yat-sen University
Second Affiliated Hospital of Guangzhou Medical University

Investigators

Study Director: Kangshun Zhu, Professor, Second Affiliated Hospital of Guangzhou Medical University
Study Director: Fei Gao, Professor, Sun Yat-sen University