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A Clinical Study of Portal Vein Embolization and Liver Venous Deprivation

U

University of Science and Technology of China (USTC)

Status

Enrolling

Conditions

Liver Venous Deprivation

Treatments

Procedure: PVE
Procedure: LVD

Study type

Interventional

Funder types

Other

Identifiers

NCT05457374
LLX-002

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

10 participants in 2 patient groups

Partial hepatectomy+LVD
Experimental group
Treatment:
Procedure: LVD
Partial hepatectomy+PVE
Experimental group
Treatment:
Procedure: PVE

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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