TIPS Combined With Microwave Ablation in HCC Patients With Refractory Ascites

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04640116
• Other study ID #: ZQFGF
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2020
• Source: Sun Yat-sen University
• Contact: Qunfnag Zhou, Professor
• Phone: 86 19868000115
• Email: zhouqun988509[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 30, 2023
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Second Affiliated Hospital of Guangzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival (OS)	the interval from TIPS to death or lost to follow-up	24 months
Secondary	change in Child-Pugh stage	the liver function stage change from C to B or from B to A	6 months
Secondary	change in Child-Pugh scores	decrease of Child-pugh scores	6 months
Secondary	Incidence of hepatic encephalopathy	the incidence of hepatic encephalopathy of patients accepting TIPS	24 months
Secondary	Varices rebleeding rate	the incidence of varices bleeding of patients accepting TIPS	24 months