A Clinical Study of Portal Vein Embolization and Liver Venous Deprivation

NCT ID: NCT05457374

Last Updated: 2022-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2025-03-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Partial hepatectomy+LVD

Group Type: EXPERIMENTAL

LVD

Intervention Type: PROCEDURE

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

Partial hepatectomy+PVE

Group Type: EXPERIMENTAL

PVE

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

LVD

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Anhui province hospital

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Lianxin Liu, M.D.

Role: primary

liulx@ustc.edu.cn

13845159888

Other Identifiers

LLX-002

Identifier Type: -

Identifier Source: org_study_id