Clinical trial NCT06366048: A Study on Relationship Between Resected Normal Liver Parenchymal Volume（RNLV）and Post-Hepatectomy Liver Failure (PHLF)
Official title: A Model Based on Resected Normal Liver Parenchymal Volume（RNLV）to Predict the Risk of Post-Hepatectomy Liver Failure (PHLF)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Liver Failure
Keywords: resected normal parenchymal volume (RNLV)
postoperative hepatectomy liver failure (PHLF)
future liver remnant (FLR)
Lead sponsor: National Natural Science Foundation of China
Sponsor class: OTHER_GOV
First posted: 2024-04-15
Enrollment: 1133
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1133 consecutive patients diagnosed with hepatocellular carcinoma (HCC) and intracholangiocarcinoma underwent hepatectomies.

Brief 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.

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

Primary outcomes:
measure: Probability of PHLF was predicted with our individual model based on RNLV.
timeFrame: postoperative day 1 to day 30.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanhai
country: China
facility: The Third Affiliated Hospital of Naval Medical University
state: Shanghai
Study officials:
affiliation: The Third Affiliated Hospital of Naval Medical University
name: Yuan-yuan Wang
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.