Portal Vein Embolization Using Coils Plus TAGM vs Multiple Coils for Patients With Perihilar Cholangiocarcinoma or Hepatocellular Carcinoma
NCT ID: NCT04386772
Last Updated: 2020-06-17
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
56 participants
INTERVENTIONAL
2020-05-27
2022-12-31
Brief Summary
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Detailed Description
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Technically, the percutaneous transhepatic approach becomes the standard of care for PVE. PVEs themselves with different embolization materials could vary in the degree of liver hypertrophy, though some techniques, such as TAE, HVE and stem cell, have been already used in combination with PVE and could promote the hypertrophy. Several aspects on the use of PVE are insufficiently studied and most recommendations are based on low-grade evidence. Large clinical studies that compare the effect of different embolic materials on the hypertrophy response are lacking. PVE using multiple coils to completely occlude all the target segmental and sectional branches is a conventional and fundamental approach in our center, which ensured a reliable hypertrophy response with a low PVE-related morbidity and post-hepatectomy liver failure rate in the past decades. PVE using with tris-acryl gelatin microspheres (TAGM) distally and coils proximally, which needs more interventional experience, has become one of standard approaches in our center. However, the study of high-grade evidence regarding the hypertrophy effect of PVE with TAGM and coils is still lacking.
In this randomized study, the investigators aim to compare PVE using TAGM plus coils to PVE using coils alone, in term of PVE-related complications, hypertrophy degree, hepatectomy completion rate, post-hepatectomy liver failure rate, features of immunohistochemical examination on parenchyma, for patients stratified by either pCCA or HCC.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PVE with coils plus TAGM
PVE with coils proximally plus TAGM distally and subsequent major hepatectomy
PVE with coils plus TAGM
PVE with TAGM distally and coils proximally and subsequent scheduled major hepatectomy. Sequential transcatheter arterial chemoembolization and PVE for patients with HCC. Selective biliary drainage on future liver remnant (FLR) side for patients with pCCA when obstructive jaundice is present.
PVE with multiple coils
PVE with multiple coils and subsequent major hepatectomy
PVE with multiple coils
Procedure: PVE with multiple coils PVE with multiple coils proximally and distally and subsequent scheduled major hepatectomy. Sequential transcatheter arterial chemoembolization and PVE for patients with HCC. Selective biliary drainage on FLR side for patients with pCCA when obstructive jaundice is present.
Interventions
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PVE with coils plus TAGM
PVE with TAGM distally and coils proximally and subsequent scheduled major hepatectomy. Sequential transcatheter arterial chemoembolization and PVE for patients with HCC. Selective biliary drainage on future liver remnant (FLR) side for patients with pCCA when obstructive jaundice is present.
PVE with multiple coils
Procedure: PVE with multiple coils PVE with multiple coils proximally and distally and subsequent scheduled major hepatectomy. Sequential transcatheter arterial chemoembolization and PVE for patients with HCC. Selective biliary drainage on FLR side for patients with pCCA when obstructive jaundice is present.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of pCCA or HCC (through imaging, serology, and/or histological biopsy)
* Performance status: Karnofsky score ≥ 70
* Candidates for right portal vein embolization for potential major hepatectomy with curative intent. Volumetric indication for PVE is less than 40% of standardized FLR.
* Selective biliary drainage on FLR side for patients with pCCA should be performed when total bilirubin level is above 85.5μmol/L or bile duct dilation of FLR presents. Transcatheter arterial chemoembolization should be performed between 1 and 4 weeks before PVE for patients with HCC.
* Criteria of liver function: Child-Pugh A-B7 level, serum total bilirubin \< 85.5μmol/L after biliary drainage in pCCA, alanine aminotransferase and aspartate aminotransferase ≤ 3 times the upper limit of normal value.
* Patients who can understand this trial and have signed the informed consent.
Exclusion Criteria
* Patients with a history of any other malignant tumor, or allergic to iodine or gelatin.
* Subjects participating in other clinical trials.
* Platelet count \< 80×109/L and/or moderate or severe esophageal varices.
* ICGR15 ≥ 15% for HCC patients
* Obstructive jaundice lasts for \>2 months before PVE for pCCA patients.
* Tumor becomes unresectable by local progression and/or distant metastasis presents before PVE.
* Right portal vein is occluded by tumor invasion or embolus before PVE.
* Free portal vein pressure \>20 mmHg or porto-hepatic vein fistula at the beginning of PVE procedure.
18 Years
70 Years
ALL
No
Sponsors
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Eastern Hepatobiliary Surgery Hospital
OTHER
Responsible Party
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Shen Feng
Professor and Chief Surgeon, Principal Investigator
Locations
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Easter hepatobiliary surgery hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EHBHKY2018-02-024
Identifier Type: -
Identifier Source: org_study_id
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