Status:
UNKNOWN
Portal Vein Embolization Using Coils Plus TAGM vs Multiple Coils for Patients With Perihilar Cholangiocarcinoma or Hepatocellular Carcinoma
Lead Sponsor:
Eastern Hepatobiliary Surgery Hospital
Conditions:
Portal Vein Occlusion
Cholangiocarcinoma, Perihilar
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 coil...
Detailed Description
Perihilar cholangiocarcinoma (pCCA) and hepatocellular carcinoma (HCC) both are common primary hepatobiliary tumors, which often require extensive hepatic resection and challenge perioperative managem...
Eligibility Criteria
Inclusion
- 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
- 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 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.
Key Trial Info
Start Date :
May 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04386772
Start Date
May 27 2020
End Date
December 1 2022
Last Update
June 17 2020
Active Locations (1)
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1
Easter hepatobiliary surgery hospital
Shanghai, Shanghai Municipality, China, 200438