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

Liver Failure Clinical Trial

— RNLV  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06366048
• Other study ID #: EHBHKY2022-K-025
• Status: Active, not recruiting
• Start date: December 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: National Natural Science Foundation of China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1133
• Est. completion date: December 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Liver Failure

Intervention

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.

Locations

Country	Name	City	State
China	The Third Affiliated Hospital of Naval Medical University	Shanhai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	postoperative day 1 to day 30.