A Study on Relationship Between Resected Normal Liver Parenchymal Volume（RNLV）and Post-Hepatectomy Liver Failure (PHLF) (RNLV)

April 9, 2026 updated by: Yuan-Yuan Wang, National Natural Science Foundation of China

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Fujian, Shanghai Municipality, China
        • Recruiting
        • Mengchao Hepatobiliary Hospital of Fujian Medical University
        • Contact:
        • Contact:
      • Shanhai, Shanghai Municipality, China, 201800
        • Recruiting
        • the Third Affiliated Hospital of Naval Medical University
        • Contact:
        • Contact:
      • Shenzhencun, Shanghai Municipality, China
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen, Mengchao Hepatobiliary Hospital of Fujian Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

1133 consecutive patients diagnosed with hepatocellular carcinoma (HCC) and intracholangiocarcinoma underwent hepatectomies.

Description

Inclusion criteria:

  • selective hepatectomies;
  • histologically confirmed as HCC and ICC
  • complete and accessible data

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PHLF group
One group was defined as post-operative liver failure accroding to the PHLF definition of 50-50 criteria and ISGLS criteria.
Diagnostic test: the different definitions of PHLF according to 50-50 criteria and ISGLS criteria
Our study respectively defined the PHLF according to the 50-50 criteria and the ISGLS criteria in literature review.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
postoperative day 1 to day 30.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Natural Science Foundation of China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yuan-yuan Wang, Eastern Hepatobiliary Surgery Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EHBHKY2022-K-025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After we published our study paper, we would like to share IPD attached to our paper as website links.

IPD Sharing Time Frame

After our paper published officially. The final time would be end of March 31st,2024.

IPD Sharing Access Criteria

Not sure now.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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