A Clinical Study of Portal Vein Embolization and Liver Venous Deprivation

Study Overview
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Brief Summary
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The main obstacle to achieving R0 resection in future liver remnant（FLR） deficient liver cancer is the inability to retain sufficient FLR to avoid postoperative liver failure. From the initial portal vein embolization(PVE), to the later ALPPS, this problem has been solved to some extent. However, both have their own shortcomings. The effect of liver hyperplasia after PVE is poor and the waiting time is long. The incidence of complication and mortality after ALPPS is always the focus of controversy. In recent years, LVD has emerged, combining PVE and HVE in the one operation. This topic will conduct a clinical controlled study of PVE and LVD.

Official Title
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A Clinical Study of Portal Vein Embolization and Liver Venous Deprivation

Conditions
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Liver Venous Deprivation

Intervention / Treatment
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* Procedure: PVE
* Procedure: LVD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ① Age 18 to 75 years old, male or female. hepatocellular liver cancer diagnosed by pathological histology, immunohistochemistry or imaging examination, with large tumor size that cannot be removed in one stage surgery No distant metastasis of the lesion. FLR<20% in patients with normal liver function; FLR<30% in patients with combined fatty liver and receiving chemotherapy; FLR<40% in compensated cirrhosis ⑤ Normal function of major organs other than liver-related functions. ⑥ Subjects voluntarily enrolled in this study, signed informed consent, good compliance, and cooperated with follow-up. Patients who the investigator believes can benefit. Exclusion Criteria: Withdrawal of consent by the subject. Having adverse reactions. ③ Failure to receive treatment due to progression. Death of the patient. Loss to follow-up. ⑥ Others.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Partial hepatectomy+PVE Partial hepatectomy+LVD
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Partial hepatectomy+LVD<br> | Procedure: LVD<br>* Combining PVE and Hepatic Vein Embolization (HVE) in the same procedure<br>|
| Experimental: Partial hepatectomy+PVE<br> | Procedure: PVE<br>* Portal vein embolization (PVE) mainly embolizes the portal vein of the resected liver lobe, causing the non-tumor lobe to proliferate, and after tumor lobectomy, the volume of the non-tumor lobe proliferates so that patients with hepatocellular carcinoma that could not be directly surgically resected are given the opportunity to be surgically resected<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FLR growth rate | FLR growth rate between two surgeries | 15days |