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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Diseases; Hepatocellular Carcinoma; Ascites; Portal Hypertension; Cirrhosis, Liver
• Intervention / Treatment: Procedure: Transjugular intrahepatic portosystemic shunt (TIPS); Procedure: microwave ablation (MWA)

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qunfnag Zhou, Professor; Phone Number: 86 19868000115; Email: zhouqun988509@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival (OS)	the interval from TIPS to death or lost to follow-up	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Second Affiliated Hospital of Guangzhou Medical University
• Investigators: Study Director: Fei Gao, Professor, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2021
• Primary Completion (ANTICIPATED): August 30, 2021
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (ACTUAL): November 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: microwave ablation; refractory ascites; Transjugular intrahepatic portosystemic shunt
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Fibrosis; Liver Diseases; Liver Cirrhosis; Ascites; Hypertension, Portal
• Other Study ID Numbers: ZQFGF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No