Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06366048

A Study on Relationship Between Resected Normal Liver Parenchymal Volume(RNLV)and 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.

Recruiting

Interested in participating?

Request Info

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Mengchao Hepatobiliary Hospital of Fujian Medical University, Fujian, Shanghai Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

the different definitions of PHLF according to 50-50 criteria and ISGLS criteria

Diagnostic Test

Our study respectively defined the PHLF according to the 50-50 criteria and the ISGLS criteria in literature review.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gang Huang

CONTACT

[email protected]

+8613918663457

Yuan-yuan Wang

CONTACT

[email protected]

+8615800332525

Sponsors and collaborators

Lead sponsor

National Natural Science Foundation of China

Other Gov

Registry information

Official study title

A Model Based on Resected Normal Liver Parenchymal Volume(RNLV)to Predict the Risk of Post-Hepatectomy Liver Failure (PHLF)

Acronym: RNLV

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2024
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.