An observational study in Liver Failure, sponsored by National Natural Science Foundation of China. Recruiting at 3 sites in China. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by National Natural Science Foundation of China · Observational
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.
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.
1133 consecutive patients diagnosed with hepatocellular carcinoma (HCC) and intracholangiocarcinoma underwent hepatectomies.
Exclusion criteria:
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
One group was defined as no post-operative liver failure accroding to the PHLF definition of 50-50 criteria nor ISGLS criteria.
Our study respectively defined the PHLF according to the 50-50 criteria and the ISGLS criteria in literature review.
Probability of PHLF was predicted with our individual model based on RNLV.
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.
Time frame: postoperative day 1 to day 30.
Plan to share: Yes — After we published our study paper, we would like to share IPD attached to our paper as website links.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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National Natural Science Foundation of China