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

N

National Natural Science Foundation of China

Status

Active, not recruiting

Conditions

Liver Failure

Treatments

Diagnostic Test: the different definitions of PHLF according to 50-50 criteria and ISGLS criteria

Study type

Observational

Funder types

Other

Identifiers

NCT06366048
EHBHKY2022-K-025

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,133 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

1,133 participants in 2 patient groups

PHLF group
Description:
One group was defined as post-operative liver failure accroding to the PHLF definition of 50-50 criteria and ISGLS criteria.
Treatment:
Diagnostic Test: the different definitions of PHLF according to 50-50 criteria and ISGLS criteria
No PHLF group
Description:
One group was defined as no post-operative liver failure accroding to the PHLF definition of 50-50 criteria nor ISGLS criteria.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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