Portal Vein Embolization Using Coils Plus TAGM vs Multiple Coils for Patients With Perihilar Cholangiocarcinoma or Hepatocellular Carcinoma

  • STATUS
    Recruiting
  • End date
    Dec 25, 2022
  • participants needed
    56
  • sponsor
    Eastern Hepatobiliary Surgery Hospital
Updated on 25 January 2021
chemoembolization
hepatectomy
cholangiocarcinoma
transcatheter arterial chemoembolisation

Summary

The aim of this study is to investigate the differences of safety and liver hypertrophy between portal vein embolization (PVE) using coils plus tris-acryl gelatin microspheres (TAGM) and multiple coils in patients with perihilar cholangiocarcinoma (pCCA) or with hepatocellular carcinoma (HCC).

Description

Perihilar cholangiocarcinoma (pCCA) and hepatocellular carcinoma (HCC) both are common primary hepatobiliary tumors, which often require extensive hepatic resection and challenge perioperative management as surgery remains the only chance of long-term survival for such patients. PVE induces effective hypertrophy on one side of the liver parenchyma ahead of a planned liver resection of the other side which becomes atrophic.

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.

Details
Condition Adenocarcinoma, Malignant Adenoma, Adenocarcinoma, HEPATIC NEOPLASM, Liver Cancer, HEPATOCELLULAR CARCINOMA, Liver Cancer, Malignant Adenoma, Portal Vein Occlusion, Cholangiocarcinoma, Perihilar, Liver; Hypertrophy, Acute, Cholangiocarcinoma, Perihilar, Liver; Hypertrophy, Acute, liver cell carcinoma, Cholangiocarcinoma, Perihilar, Liver; Hypertrophy, Acute
Treatment PVE with coils plus TAGM, PVE with multiple coils
Clinical Study IdentifierNCT04386772
SponsorEastern Hepatobiliary Surgery Hospital
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female patients > 18 years and 70 years of age
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 85.5mol/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 < 85.5mol/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 apparent cardiac, pulmonary, cerebral and renal dysfunction, which may affect the treatment
Patients with a history of any other malignant tumor, or allergic to iodine or gelatin
Subjects participating in other clinical trials
Platelet count < 80109/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
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