Portal Vein Embolization Using Coils Plus TAGM vs Multiple Coils for Patients With Perihilar Chol… (NCT04386772) | Clinical Trial Compass
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Portal Vein Embolization Using Coils Plus TAGM vs Multiple Coils for Patients With Perihilar Cholangiocarcinoma or Hepatocellular Carcinoma
China56 participantsStarted 2020-05-27
Plain-language 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).
Who can participate
Age range18 Years – 70 Years
SexALL
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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 85.5μmol/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 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 \< 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 present…