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Recruiting NCT06366048

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

— Observational Liver Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: the different definitions of PHLF according to 50-50 criteria and ISGLS criteria.
Who it may be relevant to
Registry conditions: Liver Failure. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Model Based on Resected Normal Liver Parenchymal Volume（RNLV）to Predict the Risk of Post-Hepatectomy Liver Failure (PHLF)

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.

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.

Interventions

  • Diagnostic test the different definitions of PHLF according to 50-50 criteria and ISGLS criteria
    Our study respectively defined the PHLF according to the 50-50 criteria and the ISGLS criteria in literature review.

Primary outcome measures

  • Probability of PHLF was predicted with our individual model based on RNLV. [Time frame: postoperative day 1 to day 30.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

China · 3 centers
  • Mengchao Hepatobiliary Hospital of Fujian Medical University — Fujian
  • The Third Affiliated Hospital of Naval Medical University — Shanhai
  • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen, Mengchao Hepatobiliary Hosp — Shenzhencun

Publications

  • Ioannou GN, Green P, Kerr KF, Berry K. Models estimating risk of hepatocellular carcinoma in patients with alcohol or NAFLD-related cirrhosis for risk stratification. J Hepatol. 2019 Sep;71(3):523-533. doi: 10.1016/j.jhep.2019.05.008. Epub 2019 May 28. PMID 31145929
  • Xie DY, Ren ZG, Zhou J, Fan J, Gao Q. 2019 Chinese clinical guidelines for the management of hepatocellular carcinoma: updates and insights. Hepatobiliary Surg Nutr. 2020 Aug;9(4):452-463. doi: 10.21037/hbsn-20-480. PMID 32832496
  • Renner P, Schuhbaum J, Kroemer A, Zeman F, Loss M, Lang SA, Geissler EK, Schlitt HJ, Farkas SA. Morbidity of hepatic resection for intermediate and advanced hepatocellular carcinoma. Langenbecks Arch Surg. 2016 Feb;401(1):43-53. doi: 10.1007/s00423-015-1359-y. Epub 2015 Dec 1. PMID 26627084
  • Xie QS, Chen ZX, Zhao YJ, Gu H, Geng XP, Liu FB. Systematic review of outcomes and meta-analysis of risk factors for prognosis after liver resection for hepatocellular carcinoma without cirrhosis. Asian J Surg. 2021 Jan;44(1):36-45. doi: 10.1016/j.asjsur.2020.08.019. Epub 2020 Sep 28. PMID 32988708

Identifiers

NCT: NCT06366048 · EHBHKY2022-K-025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗