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

N/AActive Not RecruitingNCT06366048

National Natural Science Foundation of China1,133 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,133

Conditions

Liver Failure

Interventions

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

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

The Third Affiliated Hospital of Naval Medical University

Shanhai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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.

Data from ClinicalTrials.gov

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