Calculator Predicts Early Mortality Post Hepatocellular Carcinoma Resection

NCT06621485 | Completed

• 1 other identifier: 24467-4-01
• Study Type: observational
• Target: 4,966
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

To Predict Early Post-hepatectomy Mortality for HCC

Keywords

Hepatocellular carcinoma; Hepatectomy; Survival; Morbidity; Futile surgery

Outcome Measures

Primary Outcomes (1)

• 90-day death

  90-day mortality after hepatectomy for HCC

  The period starts from the day of the hepatectomy surgery and extends up to the 90th day post-surgery.

Study Arms (2)

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).

Validation cohort

The validation cohort consisted of patients from the remaining two hospitals (Beijing Tsinghua Changgung Hospital and Eastern Hepatobiliary Surgery Hospital of Shanghai)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adults (age ≥18 years) who underwent curative-intent hepatectomy for newly diagnosed HCC.
• HCC diagnosis was confirmed histopathologically.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead
• Eastern Hepatobiliary Surgery Hospital of Shanghai: collaborator
• The First Hospital of Jilin University: collaborator
• Mengchao Hepatobiliary Hospital: collaborator
• The Fourth Affiliated Hospital of Harbin Medical University: collaborator
• Pu'er People's Hospital: collaborator
• Liuyang People's Hospital: collaborator
• Ziyang First People's Hospital: collaborator
• Qianfoshan Hospital: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator
• Fuyang people's hospital: collaborator

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, 102218, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 1, 2024
• Study Start: February 15, 2024
• Primary Completion: March 15, 2024
• Study Completion: March 31, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)