TIPS Combined With Microwave Ablation in HCC Patients With Refractory Ascites

NCT04640116 | Unknown DMC

• 1 other identifier: ZQFGF
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Transjugular intrahepatic portosystemic shunt; refractory ascites; microwave ablation

Outcome Measures

Primary Outcomes (1)

• overall survival (OS)

  the interval from TIPS to death or lost to follow-up

  24 months

Secondary Outcomes (4)

• change in Child-Pugh stage

  6 months

• change in Child-Pugh scores

  6 months

• Incidence of hepatic encephalopathy

  24 months

• Varices rebleeding rate

  24 months

Study Arms (1)

TIPS combined with microwave ablation

EXPERIMENTAL

Procedure: Transjugular intrahepatic portosystemic shunt (TIPS); Procedure: microwave ablation (MWA)

Interventions

Transjugular intrahepatic portosystemic shunt (TIPS) PROCEDURE

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.

TIPS combined with microwave ablation

microwave ablation (MWA) PROCEDURE

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.

TIPS combined with microwave ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-70 years
• Diagnosis of HCC based on the European Association for the Study of the Liver
• Tumor diameter ≤ 3cm
• 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

You may not qualify if:

• Congestive heart failure or severe valvular heart failure
• Uncontrolled systemic infection or inflammation
• Macroscopic vascular invasion or extrahepatic metastasis
• Severe pulmonary hypertension
• Severe renal insufficiency (except hepatogenic renal insufficiency) (6) rapidly progressive liver failure
• Diffuse malignant liver tumor
• Contrast agent allergy

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Second Affiliated Hospital of Guangzhou Medical University: collaborator

MeSH Terms

Conditions

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

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Study Officials

• Kangshun Zhu, Professor

  Second Affiliated Hospital of Guangzhou Medical University

  STUDY DIRECTOR

• Fei Gao, Professor

  Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Qunfnag Zhou, Professor

CONTACT

86 19868000115; zhouqun988509@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 23, 2020
• Study Start: February 1, 2021
• Primary Completion: August 30, 2021
• Study Completion: June 30, 2023
• Last Updated: December 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share