TIPS Combined With Microwave Ablation in HCC Patients Wit... | NCT04640116

Studies
TIPS Combined With Microwave Ablation in HCC Patients With Refractory Ascites

NCT04640116

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Dec 19, 2020Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Liver Diseases
Portal Hypertension
Cirrhosis, Liver
Ascites
Hepatocellular Carcinoma

Interventions

Transjugular intrahepatic portosystemic shunt (TIPS)
microwave ablation (MWA)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Estimated

Primary Completion Date

Aug 30, 2021Estimated

Completion Date

Jun 30, 2023Estimated

First Submitted Date

Nov 17, 2020

First Submission Date that Met QC Criteria

Nov 17, 2020

First Posted Date

Nov 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2020

Last Update Posted Date

Dec 19, 2020Actual

Name	Class
Second Affiliated Hospital of Guangzhou Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TIPS combined with microwave ablation	Experimental		Procedure: Transjugular intrahepatic portosystemic shunt (TIPS) Procedure: microwave ablation (MWA)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qunfnag Zhou, Professor	Contact	86 19868000115		zhouqun988509@163.com

Overall Officials

Name	Affiliation	Role
Kangshun Zhu, Professor	Second Affiliated Hospital of Guangzhou Medical University	Study Director
Fei Gao, Professor	Sun Yat-sen University	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008107	Liver Diseases
D006975	Hypertension, Portal
D008103	Liver Cirrhosis
D001201	Ascites
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019168	Portasystemic Shunt, Transjugular Intrahepatic

Ancestor Terms

ID	Term
D011170	Portasystemic Shunt, Surgical
D000714	Anastomosis, Surgical
D013514	Surgical Procedures, Operative
D058017	Vascular Grafting

Browse Leaves

Not provided

Browse Branches

Not provided