TIPS Combined With Microwave Ablation in HCC Patients With Refractory Ascites

Not Applicable

• Conditions: Portal Hypertension; Liver Diseases; Cirrhosis, Liver; Hepatocellular Carcinoma; Ascites
• Interventions: Procedure: Transjugular intrahepatic portosystemic shunt (TIPS); Procedure: microwave ablation (MWA)

• Registration Number: NCT04640116
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-11-17
• Study First Posted: 2020-11-23
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-19
• Study Start: 2021-02-01
• Primary Completion: 2021-08-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TIPS combined with microwave ablation	microwave ablation (MWA)	-
TIPS combined with microwave ablation	Transjugular intrahepatic portosystemic shunt (TIPS)	-

Primary Outcome Measures

Name	Time	Method
overall survival (OS)	24 months	the interval from TIPS to death or lost to follow-up

Secondary Outcome Measures

Name	Time	Method
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
change in Child-Pugh stage	6 months	the liver function stage change from C to B or from B to A