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

NCT06366048 | Recruiting

• 1 other identifier: EHBHKY2022-K-025
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 3

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.

Conditions

Liver Failure

Keywords

resected normal parenchymal volume (RNLV); postoperative hepatectomy liver failure (PHLF); future liver remnant (FLR)

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

PHLF group

One group was defined as post-operative liver failure accroding to the PHLF definition of 50-50 criteria and ISGLS criteria.

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

No PHLF group

One group was defined as no post-operative liver failure accroding to the PHLF definition of 50-50 criteria nor ISGLS criteria.

Interventions

the different definitions of PHLF according to 50-50 criteria and ISGLS criteria DIAGNOSTIC_TEST

Our study respectively defined the PHLF according to the 50-50 criteria and the ISGLS criteria in literature review.

PHLF group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1133 consecutive patients diagnosed with hepatocellular carcinoma (HCC) and intracholangiocarcinoma underwent hepatectomies.

You may qualify if:

• selective hepatectomies;
• histologically confirmed as HCC and ICC
• complete and accessible data

You may not qualify if:

• 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

Sponsors & Collaborators

• National Natural Science Foundation of China: lead

Study Sites (3)

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fujian, Shanghai Municipality, China

RECRUITING

The Third Affiliated Hospital of Naval Medical University

Shanhai, Shanghai Municipality, 201800, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen, Mengchao Hepatobiliary Hospital of Fujian Medical University

Shenzhencun, Shanghai Municipality, China

RECRUITING

Related 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.

  PMID: 31145929 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Yuan-yuan Wang

  Eastern Hepatobiliary Surgery Hospital

  STUDY DIRECTOR

Central Study Contacts

Yuan-yuan Wang

CONTACT

+8615800332525; wangyuanyuan702@foxmail.com

Gang Huang

CONTACT

+8613918663457; squaror@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: a clinical resident of general surgery department

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: December 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After our paper published officially. The final time would be end of March 31st,2024.
• Access Criteria: Not sure now.

Locations

CN (3)