A Clinical Study of Portal Vein Embolization and Liver Venous Deprivation

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Venous Deprivation
• Intervention / Treatment: Procedure: LVD; Procedure: PVE

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Recruiting
      • Anhui Province Hospital
      • Contact: Lianxin Liu, M.D.; Phone Number: 13845159888; Email: liulx@ustc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Partial hepatectomy+LVD	Procedure: LVD; Combining PVE and Hepatic Vein Embolization (HVE) in the same procedure
Experimental: Partial hepatectomy+PVE	Procedure: PVE; 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: July 10, 2022
• First Submitted That Met QC Criteria: July 10, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: LLX-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No