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TIPS Combined With Microwave Ablation in HCC Patients With Refractory Ascites

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04640116
Enrollment
30
Registered
2020-11-23
Start date
2021-02-01
Completion date
2023-06-30
Last updated
2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Transjugular intrahepatic portosystemic shunt, refractory ascites, microwave ablation

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.

Interventions

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.

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.

Sponsors

Second Affiliated Hospital of Guangzhou Medical University
CollaboratorOTHER
Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
overall survival (OS)24 monthsthe interval from TIPS to death or lost to follow-up

Secondary

MeasureTime frameDescription
Varices rebleeding rate24 monthsthe incidence of varices bleeding of patients accepting TIPS
change in Child-Pugh stage6 monthsthe liver function stage change from C to B or from B to A
change in Child-Pugh scores6 monthsdecrease of Child-pugh scores
Incidence of hepatic encephalopathy24 monthsthe incidence of hepatic encephalopathy of patients accepting TIPS

Contacts

Primary ContactQunfnag Zhou, Professor
zhouqun988509@163.com86 19868000115

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026