Liver Venous DeprivationNCT05457374
A Clinical Study of Portal Vein Embolization and Liver Venous Deprivation
A study testing PVE and LVD in people with Liver Venous Deprivation, run by Anhui Provincial Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Venous Deprivation
- What is being tested?
- PVE and LVD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anhui province hospital
Hefei, Anhui, 230000
Lianxin Liu, M.D., 13845159888, liulx@ustc.edu.cn
About this study
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
- Being tested
- PVE, LVD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVEProcedure or surgery
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
LVDProcedure or surgery
Combining PVE and Hepatic Vein Embolization (HVE) in the same procedure
| Study group | Role | What they receive |
|---|---|---|
| Partial hepatectomy+LVD | Experimental | Not described Receives: Procedure: LVD |
| Partial hepatectomy+PVE | Experimental | Not described Receives: Procedure: PVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLR growth rate
FLR growth rate between two surgeries
Measured: 15days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Mar 2022
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Venous DeprivationStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Partial hepatectomy+PVE Partial hepatectomy+LVD
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457374
- Sponsor's protocol ID
- LLX-002
- Status last verified
- May 2022
- First submitted
- 10 Jul 2022
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Portal Vein Embolization and Liver Venous Deprivation
- ClinicalTrials.gov ID
- NCT05457374
- Acronym / sponsor ID
- LLX-002
- Conditions
- Liver Venous Deprivation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Partial hepatectomy+PVE Partial hepatectomy+LVD
| Arm | Type | Receives |
|---|---|---|
| Partial hepatectomy+LVD | Experimental | Procedure: LVD |
| Partial hepatectomy+PVE | Experimental | Procedure: PVE |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ① Age 18 to 75 years old, male or female.
Key exclusion criteria (4 listed)
- Withdrawal of consent by the subject.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVEPortal 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 | Procedure or surgery | Partial hepatectomy+PVE |
| LVDCombining PVE and Hepatic Vein Embolization (HVE) in the same procedure | Procedure or surgery | Partial hepatectomy+LVD |
Primary outcome
FLR growth rate
Time frame: 15days
FLR growth rate between two surgeries
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Liver Venous Deprivation
RecruitingObservational study
DRAGON Registry - International Multicenter Registry and Medical Image Bank for Patients With Primarily Unresectable Liver Cancer or Liver Metastases That Underwent Combined Portal and Hepatic Vein Embolization (PVE/HVE) to Increase Future Liver Remnant Before Resection.
Liver Cancer, Liver Metastases
Not yet recruiting
Safety and Efficacy of LVD + C-TACE + Tis/Len for Unresectable Right-Liver HCC
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Recruiting
TANGO-LIVER Three Arm Nuclear Growth Observation in Liver Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVE and LVD in people with Liver Venous Deprivation, run by Anhui Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLR growth rate (time frame: 15days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.