To Predict Early Post-hepatectomy Mortality for HCCNCT06621485
Calculator Predicts Early Mortality Post Hepatocellular Carcinoma Resection
An observational study of To Predict Early Post-hepatectomy Mortality for HCC, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- To Predict Early Post-hepatectomy Mortality for HCC
- How many people
- 4,966 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2024to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults (age ≥18 years) who underwent curative-intent hepatectomy for newly diagnosed HCC.
- HCC diagnosis was confirmed histopathologically.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Keywords
- Hepatocellular carcinoma, Hepatectomy, Survival, Morbidity, Futile surgery
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day death
90-day mortality after hepatectomy for HCC
Measured: The period starts from the day of the hepatectomy surgery and extends up to the 90th day post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start15 Feb 2024
- Primary completion15 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Predict Early Post-hepatectomy Mortality for HCCStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 4,966 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Hepatobiliary Surgery Hospital of Shanghai, The First Hospital of Jilin University, Mengchao Hepatobiliary Hospital, The Fourth Affiliated Hospital of Harbin Medical University, Pu'er People's Hospital, Liuyang People's Hospital, Ziyang First People's Hospital, Qianfoshan Hospital, First Affiliated Hospital of Harbin Medical University, Fuyang people's hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621485
- Sponsor's protocol ID
- 24467-4-01
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-institutional Development and Validation of an Individualized Online Calculator for Early Mortality Risk After Hepatectomy Among Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06621485
- Acronym / sponsor ID
- 24467-4-01
- Keywords
- Hepatocellular carcinoma, Hepatectomy, Survival, Morbidity, Futile surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,966 participants (actual)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Collaborators
- Eastern Hepatobiliary Surgery Hospital of Shanghai, The First Hospital of Jilin University, Mengchao Hepatobiliary Hospital, The Fourth Affiliated Hospital of Harbin Medical University, Pu'er People's Hospital, Liuyang People's Hospital, Ziyang First People's Hospital, Qianfoshan Hospital, First Affiliated Hospital of Harbin Medical University, Fuyang people's hospital
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adults (age ≥18 years) who underwent curative-intent hepatectomy for newly diagnosed HCC.
- HCC diagnosis was confirmed histopathologically.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
90-day death
Time frame: The period starts from the day of the hepatectomy surgery and extends up to the 90th day post-surgery.
90-day mortality after hepatectomy for HCC
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Predict Early Post-hepatectomy Mortality for HCC, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day death (time frame: The period starts from the day of the hepatectomy surgery and extends up to the 90th day post-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.