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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06366048
Acronym
RNLV
Enrollment
1600
Registered
2024-04-15
Start date
2022-12-01
Completion date
2026-12-31
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Failure

Keywords

resected normal parenchymal volume (RNLV), postoperative hepatectomy liver failure (PHLF), future liver remnant (FLR)

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTthe 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.

Sponsors

National Natural Science Foundation of China
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Probability of PHLF was predicted with our individual model based on RNLV.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.

Countries

China

Contacts

CONTACTYuan-yuan Wang
wangyuanyuan702@foxmail.com+8615800332525
CONTACTGang Huang
squaror@163.com+8613918663457
STUDY_DIRECTORYuan-yuan Wang

Eastern Hepatobiliary Surgery Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 15, 2026