A Clinical Study of Portal Vein Embolization and Liver Venous Deprivation

Not Applicable

Recruiting

• Conditions: Liver Venous Deprivation
• Interventions: Procedure: PVE; Procedure: LVD

• Registration Number: NCT05457374
• Lead Sponsor: Anhui Provincial Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Status Verified: 2022-05
• Study First Submitted: 2022-07-10
• Study First Submitted QC: 2022-07-10
• Last Update Submitted: 2022-07-10
• Study First Posted: 2022-07-14
• Last Update Posted: 2022-07-14
• Primary Completion: 2024-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Partial hepatectomy+PVE	PVE	-
Partial hepatectomy+LVD	LVD	-

Primary Outcome Measures

Name	Time	Method
FLR growth rate	15days	FLR growth rate between two surgeries

Trial Locations

Locations (1)

Anhui province hospital; 🇨🇳 Hefei, Anhui, China