TIPS Combined With Microwave Ablation in HCC Patients With Refractory Ascites
NCT ID: NCT04640116
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2021-02-01
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TIPS combined with microwave ablation
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Second Affiliated Hospital of Guangzhou Medical University
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Zhou Qunfang
Professor
Principal Investigators
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Kangshun Zhu, Professor
Role: STUDY_DIRECTOR
Second Affiliated Hospital of Guangzhou Medical University
Fei Gao, Professor
Role: STUDY_DIRECTOR
Sun Yat-sen University
Central Contacts
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Other Identifiers
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ZQFGF
Identifier Type: -
Identifier Source: org_study_id