Liver DiseasesNCT04640116
TIPS Combined With Microwave Ablation in HCC Patients With Refractory Ascites
A study testing Transjugular intrahepatic portosystemic shunt (TIPS) and microwave ablation (MWA) in people with Liver Diseases and Portal Hypertension, run by Sun Yat-sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Diseases, Portal Hypertension, Cirrhosis, Liver
- What is being tested?
- Transjugular intrahepatic portosystemic shunt (TIPS) and microwave ablation (MWA)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Being tested
- Transjugular intrahepatic portosystemic shunt (TIPS), microwave ablation (MWA)
- Keywords
- Transjugular intrahepatic portosystemic shunt, refractory ascites, microwave ablation
- Medical subject headings
- Liver Diseases, Hypertension, Portal, Liver Cirrhosis, Ascites, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transjugular intrahepatic portosystemic shunt (TIPS)Procedure or surgery
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.
microwave ablation (MWA)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| TIPS combined with microwave ablation | Experimental | Not described Receives: Procedure: Transjugular intrahepatic portosystemic shunt (TIPS); Procedure: microwave ablation (MWA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS)
the interval from TIPS to death or lost to follow-up
Measured: 24 months
Secondary outcomes (4)
change in Child-Pugh stage
the liver function stage change from C to B or from B to A
Measured: 6 months
change in Child-Pugh scores
decrease of Child-pugh scores
Measured: 6 months
Incidence of hepatic encephalopathy
the incidence of hepatic encephalopathy of patients accepting TIPS
Measured: 24 months
Varices rebleeding rate
the incidence of varices bleeding of patients accepting TIPS
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start1 Feb 2021 (estimated)
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Qunfang, Sun Yat-sen University
- Investigators
- Kangshun Zhu, Professor, Study director, Second Affiliated Hospital of Guangzhou Medical UniversityFei Gao, Professor, Study director, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640116
- Sponsor's protocol ID
- ZQFGF
- Status last verified
- Nov 2020
- First submitted
- 17 Nov 2020
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Clinical Outcome of TIPS Combined With Subsequent Microwave Ablation in HCC Patients With Refractory Ascites
- ClinicalTrials.gov ID
- NCT04640116
- Acronym / sponsor ID
- ZQFGF
- Keywords
- Transjugular intrahepatic portosystemic shunt, refractory ascites, microwave ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Guangzhou Medical University
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TIPS combined with microwave ablation | Experimental | Procedure: Transjugular intrahepatic portosystemic shunt (TIPS), Procedure: microwave ablation (MWA) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | TIPS combined with microwave ablation |
| 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. | Procedure or surgery | TIPS combined with microwave ablation |
Primary outcome
overall survival (OS)
Time frame: 24 months
the interval from TIPS to death or lost to follow-up
4 secondary outcomes
change in Child-Pugh stage
Time frame: 6 months
change in Child-Pugh scores
Time frame: 6 months
Incidence of hepatic encephalopathy
Time frame: 24 months
Varices rebleeding rate
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kangshun Zhu, Professor study director
Second Affiliated Hospital of Guangzhou Medical University
Fei Gao, Professor study director
Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A study testing Transjugular intrahepatic portosystemic shunt (TIPS) and microwave ablation (MWA) in people with Liver Diseases and Portal Hypertension, run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qunfnag Zhou, Professor (86 19868000115, zhouqun988509@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (OS) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.