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RecruitingNCT06366048

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
Phase
Study type
Observational
Enrollment
1,600 (estimated)
Sponsor
National Natural Science Foundation of China · Other Government
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTthe different definitions of PHLF according to 50-50 criteria and ISGLS criteriaOur study respectively defined the PHLF according to the 50-50 criteria and the ISGLS criteria in literature review.

Timeline

Start date
2022-12-01
Primary completion
2026-12-31
Completion
2026-12-31
First posted
2024-04-15
Last updated
2026-04-14

Locations

3 sites across 1 country: China

Source: ClinicalTrials.gov record NCT06366048. Inclusion in this directory is not an endorsement.