Clinical trial NCT04640116: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Diseases
Portal Hypertension
Cirrhosis, Liver
Ascites
Hepatocellular Carcinoma
Keywords: Transjugular intrahepatic portosystemic shunt
refractory ascites
microwave ablation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Guangzhou Medical University
First posted: 2020-11-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: overall survival (OS)
timeFrame: 24 months
Secondary outcomes:
measure: change in Child-Pugh stage
timeFrame: 6 months
measure: change in Child-Pugh scores
timeFrame: 6 months
measure: Incidence of hepatic encephalopathy
timeFrame: 24 months
measure: Varices rebleeding rate
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Second Affiliated Hospital of Guangzhou Medical University
name: Kangshun Zhu, Professor
role: STUDY_DIRECTOR
affiliation: Sun Yat-sen University
name: Fei Gao, Professor
role: STUDY_DIRECTOR
References: