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

Active, not recruiting
Conditions
Liver Failure
Interventions
Diagnostic Test: the different definitions of PHLF according to 50-50 criteria and ISGLS criteria
Registration Number
NCT06366048
Lead Sponsor
National Natural Science Foundation of China
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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
1133
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
PHLF groupthe 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.
Primary Outcome Measures
NameTimeMethod
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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

The Third Affiliated Hospital of Naval Medical University

🇨🇳

Shanhai, Shanghai, China

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