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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 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

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
Intervention / Treatment
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

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

National Natural Science Foundation of China

Investigators

  • 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)

December 1, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 10, 2024

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Actual)

April 15, 2024

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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