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

NCT ID: NCT06366048

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Liver Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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PHLF group

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

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

Intervention Type DIAGNOSTIC_TEST

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

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.

No interventions assigned to this group

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role lead

Responsible Party

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Yuan-Yuan Wang

a clinical resident of general surgery department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuan-yuan Wang

Role: STUDY_DIRECTOR

The Third Affiliated Hospital of Naval Medical University

Locations

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The Third Affiliated Hospital of Naval Medical University

Shanhai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 31145929 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32832496 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26627084 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32988708 (View on PubMed)

Other Identifiers

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EHBHKY2022-K-025

Identifier Type: -

Identifier Source: org_study_id

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