Back to resultsA Clinical Study of Portal Vein Embolization and Liver Venous Deprivation
Primary Purpose
Liver Venous Deprivation
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PVE
LVD
Sponsored by
About this trial
This is an interventional treatment trial for Liver Venous Deprivation
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.
Sites / Locations
- Anhui province hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Partial hepatectomy+LVD
Partial hepatectomy+PVE
Arm Description
Outcomes
Primary Outcome Measures
FLR growth rate
FLR growth rate between two surgeries
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05457374
Brief Title
A Clinical Study of Portal Vein Embolization and Liver Venous Deprivation
Official Title
A Clinical Study of Portal Vein Embolization and Liver Venous Deprivation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anhui Provincial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Venous Deprivation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Partial hepatectomy+PVE Partial hepatectomy+LVD
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Partial hepatectomy+LVD
Arm Type
Experimental
Arm Title
Partial hepatectomy+PVE
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
PVE
Intervention Description
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
Intervention Name(s)
LVD
Intervention Description
Combining PVE and Hepatic Vein Embolization (HVE) in the same procedure
Primary Outcome Measure Information:
Title
FLR growth rate
Description
FLR growth rate between two surgeries
Time Frame
15days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Anhui province hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lianxin Liu, M.D.
Phone
13845159888
Email
liulx@ustc.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Study of Portal Vein Embolization and Liver Venous Deprivation
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