Calculator Predicts Early Mortality Post Hepatocellular Carcinoma Resection
September 29, 2024 updated by: Beijing Tsinghua Chang Gung Hospital
Multi-institutional Development and Validation of an Individualized Online Calculator for Early Mortality Risk After Hepatectomy Among Patients With Hepatocellular Carcinoma
Using the multicenter data, we developed and validated an individualized online calculator to predict early mortality after liver resection for hepatocellular carcinoma.
The user-friendly tool with 6 preoperative predictors demonstrated excellent accuracy.
The freely available calculator may help identify high-risk patients and reduce futile liver resection for hepatocellular carcinoma.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
4966
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 102218
- Beijing Tsinghua Changgung Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The final analytic cohort was comprised of 4,966 HCC patients treated with hepatectomy with curative intent across 11 hospitals; 3,433 patients were in the 9-center training cohort and 1,533 in the 2-center external validation cohort.
Description
Inclusion Criteria:
Adults (age ≥18 years) who underwent curative-intent hepatectomy for newly diagnosed HCC.
HCC diagnosis was confirmed histopathologically.
Exclusion Criteria:
Patients undergoing emergency hepatectomy for tumor rupture, as well as individuals with recurrent HCC, and those with missing survival data or less than 90 days of follow-up were excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Training cohort
The training cohort was comprised of patients from 9 participating hospitals (First Hospital of Jilin University, Mengchao Hepatobiliary Hospital, the Fourth Hospital of Harbin, Pu'er People's Hospital, Liuyang People's Hospital, Ziyang First People's Hospital, First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, First Affiliated Hospital of Harbin Medical University, and Fuyang People's Hospital).
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Validation cohort
The validation cohort consisted of patients from the remaining two hospitals (Beijing Tsinghua Changgung Hospital and Eastern Hepatobiliary Surgery Hospital of Shanghai)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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90-day death
Time Frame: The period starts from the day of the hepatectomy surgery and extends up to the 90th day post-surgery.
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90-day mortality after hepatectomy for HCC
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The period starts from the day of the hepatectomy surgery and extends up to the 90th day post-surgery.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2024
Primary Completion (Actual)
March 15, 2024
Study Completion (Actual)
March 31, 2024
Study Registration Dates
First Submitted
September 29, 2024
First Submitted That Met QC Criteria
September 29, 2024
First Posted (Actual)
October 1, 2024
Study Record Updates
Last Update Posted (Actual)
October 1, 2024
Last Update Submitted That Met QC Criteria
September 29, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24467-4-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.