Liver FailureRNLVNCT06366048
A Study on Relationship Between Resected Normal Liver Parenchymal Volume（RNLV）and Post-Hepatectomy Liver Failure (PHLF)
An observational study of Liver Failure, run by National Natural Science Foundation of China at 3 sites in China.
Trial summary
The post-hepatotectomy liver failure (PHLF) is still the most worrisome complication of hepatic resection. Surgeons have always been making efforts to preoperatively predict PHLF using kinds of techniques, scoring systems, and variables. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Failure
- What is being tested?
- the different definitions of PHLF according to 50-50 criteria and ISGLS criteria
- How many people
- 1,600 participants
- Where
- 3 sitesChina
- Study dates
- 1 Dec 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1133 consecutive patients diagnosed with hepatocellular carcinoma (HCC) and intracholangiocarcinoma underwent hepatectomies.
Who may be able to join
- selective hepatectomies;
- histologically confirmed as HCC and ICC
- complete and accessible data
Who cannot join
- any history of Associated Liver Partition and Portal vein ligation for Staged hepatectomy (ALPPS)
- any history of portal vein embolism (PVE)
- any history of tumor rupture
- emergency surgery
- pathologically diagnosed with neither HCC nor ICC
- concomitant resection of gastrointestinal organs, spleenectomy or other organs
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fujian, Shanghai Municipality
Gang Huang, +8613918663457, squaror@163.com
Yuanyuan Wang, +8615800332525, wangyuanyuan702@foxmail.com
- Recruiting
The Third Affiliated Hospital of Naval Medical University
Shanhai, Shanghai Municipality, 201800
Gang Huang, +8613918663457, squaror@163.com
Yuanyuan Wang, +8615800332525, wangyuanyuan702@foxmail.com
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen, Mengchao Hepatobiliary Hospital of Fujian Medical University
Shenzhencun, Shanghai Municipality
Gang Huang, +8613918663457, squaror@163.com
Yuanyuan Wang, +8615800332525, wangyuanyuan702@foxmail.com
About this study
Official title: A Model Based on Resected Normal Liver Parenchymal Volume（RNLV）to Predict the Risk of Post-Hepatectomy Liver Failure (PHLF)
The post-hepatotectomy liver failure (PHLF) is still the most worrisome complication of hepatic resection. Surgeons have always been making efforts to preoperatively predict PHLF using kinds of techniques, scoring systems, and variables. The investigators of this study tried to create an individual predictive model based on the variable, resected normal parenchymal volume (RNLV), then assessing the performance and value of the model in clinical practice.
Read the detailed description
The investigator launched a large sample-size and retrospective study, enrolling more than a thousand consecutive patients diagnosed with hepatocellular carcinoma (HCC) and intracholangiocarcinoma (ICC) underwent hepatotectomy from the investigator's center. The primary aim of study was to identify whether there was strong correlation between RNLV and PHLF, and the second aim was to further build a combination model based on RNLV and evaluate the value of predicting PHLF in clinical practice. The investigators attached same importance to RNLV, compared to future liver remnant, especially for patients with massive tumors and multiple tumors. The investigators hyperthesized that RNLV could be an indicative variable for surgical safety, and help to form a diversifying method to comprehensively assess the risk of PHLF preoperatively.
- Conditions
- Liver Failure
- Being tested
- the different definitions of PHLF according to 50-50 criteria and ISGLS criteria
- Keywords
- resected normal parenchymal volume (RNLV), postoperative hepatectomy liver failure (PHLF), future liver remnant (FLR)
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the different definitions of PHLF according to 50-50 criteria and ISGLS criteriaDiagnostic test
Our study respectively defined the PHLF according to the 50-50 criteria and the ISGLS criteria in literature review.
| Study group | Role | What they receive |
|---|---|---|
| PHLF group | One group was defined as post-operative liver failure accroding to the PHLF definition of 50-50 criteria and ISGLS criteria. Receives: Diagnostic Test: the different definitions of PHLF according to 50-50 criteria and ISGLS criteria | |
| No PHLF group | One group was defined as no post-operative liver failure accroding to the PHLF definition of 50-50 criteria nor ISGLS criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of PHLF was predicted with our individual model based on RNLV.
In our center, an increase international normalized ratio greater than 1.15 and concomitant hyperbilirubinemia more than 23μmol/L on or after postoperative day 5 would be defined as PHLF, according to the International Study Group of Liver Surgery.
Measured: postoperative day 1 to day 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Dec 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Natural Science Foundation of China
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yuan-Yuan Wang, National Natural Science Foundation of China
- Investigators
- Yuan-yuan Wang, Study director, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366048
- Sponsor's protocol ID
- EHBHKY2022-K-025
- Acronym
- RNLV
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After we published our study paper, we would like to share IPD attached to our paper as website links.
Publications
Ioannou GN, Green P, Kerr KF, Berry K. Models estimating risk of hepatocellular carcinoma in patients with alcohol or NAFLD-related cirrhosis for risk stratification. J Hepatol. 2019 Sep;71(3):523-533. doi: 10.1016/j.jhep.2019.05.008. Epub 2019 May 28.
PubMed 31145929Xie DY, Ren ZG, Zhou J, Fan J, Gao Q. 2019 Chinese clinical guidelines for the management of hepatocellular carcinoma: updates and insights. Hepatobiliary Surg Nutr. 2020 Aug;9(4):452-463. doi: 10.21037/hbsn-20-480.
PubMed 32832496Renner P, Schuhbaum J, Kroemer A, Zeman F, Loss M, Lang SA, Geissler EK, Schlitt HJ, Farkas SA. Morbidity of hepatic resection for intermediate and advanced hepatocellular carcinoma. Langenbecks Arch Surg. 2016 Feb;401(1):43-53. doi: 10.1007/s00423-015-1359-y. Epub 2015 Dec 1.
PubMed 26627084Xie QS, Chen ZX, Zhao YJ, Gu H, Geng XP, Liu FB. Systematic review of outcomes and meta-analysis of risk factors for prognosis after liver resection for hepatocellular carcinoma without cirrhosis. Asian J Surg. 2021 Jan;44(1):36-45. doi: 10.1016/j.asjsur.2020.08.019. Epub 2020 Sep 28.
PubMed 32988708
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Model Based on Resected Normal Liver Parenchymal Volume（RNLV）to Predict the Risk of Post-Hepatectomy Liver Failure (PHLF)
- ClinicalTrials.gov ID
- NCT06366048
- Acronym / sponsor ID
- RNLV / EHBHKY2022-K-025
- Conditions
- Liver Failure
- Keywords
- resected normal parenchymal volume (RNLV), postoperative hepatectomy liver failure (PHLF), future liver remnant (FLR)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- National Natural Science Foundation of ChinaOther government
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Apr 2024 (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 post-hepatotectomy liver failure (PHLF) is still the most worrisome complication of hepatic resection. Surgeons have always been making efforts to preoperatively predict PHLF using kinds of techniques, scoring systems, and variables. The investigators of this study tried to create an individual predictive model based on the variable, resected normal parenchymal volume (RNLV), then assessing the performance and value of the model in clinical practice.
Detailed description
The investigator launched a large sample-size and retrospective study, enrolling more than a thousand consecutive patients diagnosed with hepatocellular carcinoma (HCC) and intracholangiocarcinoma (ICC) underwent hepatotectomy from the investigator's center. The primary aim of study was to identify whether there was strong correlation between RNLV and PHLF, and the second aim was to further build a combination model based on RNLV and evaluate the value of predicting PHLF in clinical practice. The investigators attached same importance to RNLV, compared to future liver remnant, especially for patients with massive tumors and multiple tumors. The investigators hyperthesized that RNLV could be an indicative variable for surgical safety, and help to form a diversifying method to comprehensively assess the risk of PHLF preoperatively.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHLF group | – | Diagnostic Test: the different definitions of PHLF according to 50-50 criteria and ISGLS criteriaOne group was defined as post-operative liver failure accroding to the PHLF definition of 50-50 criteria and ISGLS criteria. |
| No PHLF group | – | –One group was defined as no post-operative liver failure accroding to the PHLF definition of 50-50 criteria nor ISGLS criteria. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1133 consecutive patients diagnosed with hepatocellular carcinoma (HCC) and intracholangiocarcinoma underwent hepatectomies.
Key inclusion criteria (3 listed)
- selective hepatectomies;
- histologically confirmed as HCC and ICC
- complete and accessible data
Key exclusion criteria (6 listed)
- any history of Associated Liver Partition and Portal vein ligation for Staged hepatectomy (ALPPS)
- any history of portal vein embolism (PVE)
- any history of tumor rupture
- emergency surgery
- pathologically diagnosed with neither HCC nor ICC
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 |
|---|---|---|
| the different definitions of PHLF according to 50-50 criteria and ISGLS criteriaOur study respectively defined the PHLF according to the 50-50 criteria and the ISGLS criteria in literature review. | Diagnostic test | PHLF group |
Primary outcome
Probability of PHLF was predicted with our individual model based on RNLV.
Time frame: postoperative day 1 to day 30.
In our center, an increase international normalized ratio greater than 1.15 and concomitant hyperbilirubinemia more than 23μmol/L on or after postoperative day 5 would be defined as PHLF, according to the International Study Group of Liver Surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Background: PubMed 31145929Ioannou GN, Green P, Kerr KF, Berry K. Models estimating risk of hepatocellular carcinoma in patients with alcohol or NAFLD-related cirrhosis for risk stratification. J Hepatol. 2019 Sep;71(3):523-533. doi: 10.1016/j.jhep.2019.05.008. Epub 2019 May 28.
- Background: PubMed 32832496Xie DY, Ren ZG, Zhou J, Fan J, Gao Q. 2019 Chinese clinical guidelines for the management of hepatocellular carcinoma: updates and insights. Hepatobiliary Surg Nutr. 2020 Aug;9(4):452-463. doi: 10.21037/hbsn-20-480.
- Background: PubMed 26627084Renner P, Schuhbaum J, Kroemer A, Zeman F, Loss M, Lang SA, Geissler EK, Schlitt HJ, Farkas SA. Morbidity of hepatic resection for intermediate and advanced hepatocellular carcinoma. Langenbecks Arch Surg. 2016 Feb;401(1):43-53. doi: 10.1007/s00423-015-1359-y. Epub 2015 Dec 1.
- Background: PubMed 32988708Xie QS, Chen ZX, Zhao YJ, Gu H, Geng XP, Liu FB. Systematic review of outcomes and meta-analysis of risk factors for prognosis after liver resection for hepatocellular carcinoma without cirrhosis. Asian J Surg. 2021 Jan;44(1):36-45. doi: 10.1016/j.asjsur.2020.08.019. Epub 2020 Sep 28.
- Individual participant dataSharing planned: Yes. After we published our study paper, we would like to share IPD attached to our paper as website links.
Related trials for Liver Failure
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Effect of Mini-Program Monitoring on Hepatic Encephalopathy in Post-TIPS Patients
Hepatic Encephalopathy, Liver Cirrhosis
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
RecruitingObservational study
Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues
Heart Failure, Liver Fibrosis
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.
Yuan-yuan Wang study director
Eastern Hepatobiliary Surgery Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Failure, run by National Natural Science Foundation of China at 3 sites 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan-yuan Wang (+8615800332525, wangyuanyuan702@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probability of PHLF was predicted with our individual model based on RNLV. (time frame: postoperative day 1 to day 30.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06366048, which also lists 4 linked publications.
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 Apr 2026.