A Clinical Study of Portal Vein Embolization and Liver Venous Deprivation

NCT05457374 | Unknown

• 1 other identifier: LLX-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Venous Deprivation

Outcome Measures

Primary Outcomes (1)

• FLR growth rate

  FLR growth rate between two surgeries

  15days

Study Arms (2)

Partial hepatectomy+LVD

EXPERIMENTAL

Procedure: LVD

Partial hepatectomy+PVE

EXPERIMENTAL

Procedure: PVE

Interventions

PVE PROCEDURE

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

Partial hepatectomy+PVE

LVD PROCEDURE

Combining PVE and Hepatic Vein Embolization (HVE) in the same procedure

Partial hepatectomy+LVD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Anhui province hospital

Hefei, Anhui, 230000, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Partial hepatectomy+PVE Partial hepatectomy+LVD

Study Record Dates

• First Submitted: July 10, 2022
• First Posted: July 14, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2025
• Last Updated: July 14, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)