Liver Failure After Operative ProcedurePHLF predictioNCT05779098
A Machine Learning Architecture to Predict Post-Hepatectomy Liver Failure Using Liver Regeneration Biomarkers and Time-Phased Data
An observational study of Liver Failure After Operative Procedure, run by Shen Feng at 1 site in China.
Trial summary
Post-hepatectomy liver failure (PHLF) is the leading cause of morbidity and mortality following major hepatectomy. Existing prediction models fail to capture the dynamic liver regeneration and perioperative changes, limiting their predictive accuracy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Failure After Operative Procedure
- How many people
- 1,071 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 1 Apr 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Extensive Hepatology in our hospital
Who may be able to join
- Extensive hepatectomy in our hospital（≥ three Hepatic segment）
Who cannot join
- Serious basic diseases Intolerable surgery Refuse to perform ICG test before operation
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Hepatobiliary and Pancreatic Surgery, Tenth People's Hospital of Tongji University, School of Medicine, Tongji University, Shanghai, China
Shanghai, 200092
About this study
Post-hepatectomy liver failure (PHLF) is the leading cause of morbidity and mortality following major hepatectomy. Existing prediction models fail to capture the dynamic liver regeneration and perioperative changes, limiting their predictive accuracy. We aimed to develop a machine learning (ML) modelling system (PILOT architecture) integrating liver regeneration biomarkers with time-phased perioperative clinical data to accurately predict PHLF risk.
- Conditions
- Liver Failure After Operative Procedure
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 |
|---|---|---|
| Extensive hepatectomy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative liver failure
Measured: 1-5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start1 Apr 2023
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver Failure After Operative ProcedureStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,071 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shen Feng
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 10th People's Hospital, Jinling Hospital, China
- Responsible party
- Sponsor-investigator, Shen Feng, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779098
- Sponsor's protocol ID
- 1312871874
- Acronym
- PHLF predictio
- Status last verified
- May 2025
- First submitted
- 9 Mar 2023
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shen H, Yuan T, Si A, Shen Y, Liu J, Jin L, Xie Z, Zhang H, Wei W, Dai Y, Jiang T, He C, Zhang S, Hu Y, Huang S, Yang Z, Chen Y, Zhang X, Shen F, Qi X, Li J. Liver regeneration-associated machine learning architecture integrating time-phased predictions for post-hepatectomy liver failure. EClinicalMedicine. 2025 Nov 28;90:103661. doi: 10.1016/j.eclinm.2025.103661. eCollection 2025 Dec.
PubMed 41399475
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Machine Learning Architecture to Predict Post-Hepatectomy Liver Failure Using Liver Regeneration Biomarkers and Time-Phased Data
- ClinicalTrials.gov ID
- NCT05779098
- Acronym / sponsor ID
- PHLF predictio / 1312871874
- Conditions
- Liver Failure After Operative Procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,071 participants (actual)
- Lead sponsor
- Shen FengUniversity, hospital or other
- Collaborators
- Shanghai 10th People's Hospital, Jinling Hospital, China
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 22 Mar 2023 (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.
Post-hepatectomy liver failure (PHLF) is the leading cause of morbidity and mortality following major hepatectomy. Existing prediction models fail to capture the dynamic liver regeneration and perioperative changes, limiting their predictive accuracy. We aimed to develop a machine learning (ML) modelling system (PILOT architecture) integrating liver regeneration biomarkers with time-phased perioperative clinical data to accurately predict PHLF risk.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extensive hepatectomy | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Extensive Hepatology in our hospital
Key inclusion criteria (1 listed)
- Extensive hepatectomy in our hospital（≥ three Hepatic segment）
Key exclusion criteria (1 listed)
- Serious basic diseases Intolerable surgery Refuse to perform ICG test before operation
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
Postoperative liver failure
Time frame: 1-5 days after surgery
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 22 May 2025.
- Derived from this study: PubMed 41399475Shen H, Yuan T, Si A, Shen Y, Liu J, Jin L, Xie Z, Zhang H, Wei W, Dai Y, Jiang T, He C, Zhang S, Hu Y, Huang S, Yang Z, Chen Y, Zhang X, Shen F, Qi X, Li J. Liver regeneration-associated machine learning architecture integrating time-phased predictions for post-hepatectomy liver failure. EClinicalMedicine. 2025 Nov 28;90:103661. doi: 10.1016/j.eclinm.2025.103661. eCollection 2025 Dec.
- Individual participant dataSharing planned: No
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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 Liver Failure After Operative Procedure, run by Shen Feng 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 1 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 22 May 2025. 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?
Postoperative liver failure (time frame: 1-5 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05779098, which also lists 1 linked publication.
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 22 May 2025.