NCT05457374RecruitingNot Applicable
A Clinical Study of Portal Vein Embolization and Liver Venous Deprivation
Anhui Provincial Hospital1 site in 1 country10 target enrollmentStarted: March 1, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- FLR growth rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
FLR growth rate
Time Frame: 15days
FLR growth rate between two surgeries
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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