Liver FailureNCT06532214
Clinical Retrospective Study Analysis of Postoperative Complications Following Hepatectomy
An observational study of Liver Failure and Liver Dysfunction, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Hepatectomy is a crucial surgical method for treating liver diseases such as liver cancer, hepatic hemangiomas, and biliary stones. Although hepatectomy has achieved significant therapeutic effects, postoperative complications remain an inevitable issue. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Failure, Liver Dysfunction
- What is being tested?
- International Study Group for Liver Surgery (ISGLS)
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 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
- Adult, Older adult
Study population: Patients who underwent liver resection surgery at the participating centers
Who may be able to join
- 1. Patients aged 18-80 years 2.Patients who underwent liver resection surgery at the participating centers
Who cannot join
- Prior cancer treatments such as transarterial chemoembolization, ablation, or targeted therapy.
- Repeat liver resection surgeries.
- Presence of other malignancies.
- Concurrent end-stage diseases including active infections, respiratory failure, decompensated heart failure, and autoimmune disease exacerbations.
- Inadequate clinical data availability in medical records.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong, 510515
kai wang, 13710574386, kaiwang@smu.edu.cn
About this study
Hepatectomy is a crucial surgical method for treating liver diseases such as liver cancer, hepatic hemangiomas, and biliary stones. Although hepatectomy has achieved significant therapeutic effects, postoperative complications remain an inevitable issue. Complications following hepatectomy include liver failure, hepatic vascular thrombosis, wound infection at the hepatic incision, and bile leakage, among others. These complications pose a serious threat to patients' health and life, and also increase the waste of medical resources and the cost of treatment. Currently, research on postoperative complications of hepatectomy mainly focuses on small sample studies from a single center, and most studies only focus on a specific complication, lacking comprehensive and systematic analysis. Therefore, it is necessary to conduct a retrospective study analysis of complications related to hepatectomy to more comprehensively and objectively understand the incidence, risk factors, prevention, and treatment of postoperative complications, providing clinical doctors with more scientific treatment plans and guidance.
- Conditions
- Liver Failure, Liver Dysfunction
- Being tested
- International Study Group for Liver Surgery (ISGLS)
- Keywords
- hepatectomy, liver failure, Post-hepatectomy liver failure
- Medical subject headings
- Liver Failure, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
International Study Group for Liver Surgery (ISGLS)Diagnostic test
According to the ISGLS criteria, the patient was judged to have liver failure and further analysis
| Study group | Role | What they receive |
|---|---|---|
| PHLF/NPHLF | PHLF:Post-hepatectomy liver failure,PHLF is commonly diagnosed and classified according to the criteria of the International Study Group for Liver Surgery (ISGLS), utilizing markers of liver function measured on or after postoperative day 5 (POD5). NPHLF:Patients who did not experience liver failure following hepatectomy. Receives: Diagnostic Test: International Study Group for Liver Surgery (ISGLS) | |
| Liver Cirrhosis/No Liver Cirrhosis | Whether the patient has cirrhosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-hepatectomy liver failure (PHLF)
PHLF is commonly diagnosed and classified according to the criteria of the International Study Group for Liver Surgery (ISGLS), utilizing markers of liver function measured on or after postoperative day 5 (POD5).
Measured: On and after the 5th postoperative day
Secondary outcomes (1)
mortality
The patient died postoperatively
Measured: During 30 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 posted1 Aug 2024
- Study start1 Jan 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
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 FailureStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532214
- Sponsor's protocol ID
- NFEC-2023-245
- Status last verified
- Jul 2024
- First submitted
- 29 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: To ensure the protection of patients' clinical information data, ethical committee approval is required before sharing data with other research studies. This process is crucial for maintaining patient confidentiality and adhering to privacy regulations and ethical standards in research.
Publications
Wang K, Yang Q, Li K, Tang S, Zhang B, Liao X, Du S, Fu W, Li Z, Chen H, Xie H, Huang P, Li J, Wang Q, Liu H, Huang Z, Heng PA, Wan X, Li C, Si W. Learning-based early detection of post-hepatectomy liver failure using temporal perioperative data: a nationwide multicenter retrospective study in China. EClinicalMedicine. 2025 May 6;83:103220. doi: 10.1016/j.eclinm.2025.103220. eCollection 2025 May.
PubMed 40630620
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Retrospective Study Analysis of Postoperative Complications Following Hepatectomy
- ClinicalTrials.gov ID
- NCT06532214
- Acronym / sponsor ID
- NFEC-2023-245
- Conditions
- Liver Failure, Liver Dysfunction
- Keywords
- hepatectomy, liver failure, Post-hepatectomy liver failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Aug 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.
Hepatectomy is a crucial surgical method for treating liver diseases such as liver cancer, hepatic hemangiomas, and biliary stones. Although hepatectomy has achieved significant therapeutic effects, postoperative complications remain an inevitable issue. Complications following hepatectomy include liver failure, hepatic vascular thrombosis, wound infection at the hepatic incision, and bile leakage, among others. These complications pose a serious threat to patients' health and life, and also increase the waste of medical resources and the cost of treatment. Currently, research on postoperative complications of hepatectomy mainly focuses on small sample studies from a single center, and most studies only focus on a specific complication, lacking comprehensive and systematic analysis. Therefore, it is necessary to conduct a retrospective study analysis of complications related to hepatectomy to more comprehensively and objectively understand the incidence, risk factors, prevention, and treatment of postoperative complications, providing clinical doctors with more scientific treatment plans and guidance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHLF/NPHLF | – | Diagnostic Test: International Study Group for Liver Surgery (ISGLS)PHLF:Post-hepatectomy liver failure,PHLF is commonly diagnosed and classified according to the criteria of the International Study Group for Liver Surgery (ISGLS), utilizing markers of liver function measured on or after postoperative day 5 (POD5). NPHLF:Patients who did not experience liver failure following hepatectomy. |
| Liver Cirrhosis/No Liver Cirrhosis | – | –Whether the patient has cirrhosis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent liver resection surgery at the participating centers
Key inclusion criteria (1 listed)
- 1. Patients aged 18-80 years 2.Patients who underwent liver resection surgery at the participating centers
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| International Study Group for Liver Surgery (ISGLS)According to the ISGLS criteria, the patient was judged to have liver failure and further analysis | Diagnostic test | PHLF/NPHLF |
Primary outcome
Post-hepatectomy liver failure (PHLF)
Time frame: On and after the 5th postoperative day
PHLF is commonly diagnosed and classified according to the criteria of the International Study Group for Liver Surgery (ISGLS), utilizing markers of liver function measured on or after postoperative day 5 (POD5).
1 secondary outcome
mortality
Time frame: During 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Derived from this study: PubMed 40630620Wang K, Yang Q, Li K, Tang S, Zhang B, Liao X, Du S, Fu W, Li Z, Chen H, Xie H, Huang P, Li J, Wang Q, Liu H, Huang Z, Heng PA, Wan X, Li C, Si W. Learning-based early detection of post-hepatectomy liver failure using temporal perioperative data: a nationwide multicenter retrospective study in China. EClinicalMedicine. 2025 May 6;83:103220. doi: 10.1016/j.eclinm.2025.103220. eCollection 2025 May.
- Individual participant dataSharing planned: Undecided. To ensure the protection of patients' clinical information data, ethical committee approval is required before sharing data with other research studies. This process is crucial for maintaining patient confidentiality and adhering to privacy regulations and ethical standards in research.
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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.
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 and Liver Dysfunction, run by Nanfang Hospital, Southern Medical University 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 5 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: status not confirmed, as of the sponsor's last update on 1 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Wang (13710574386, kaiwang@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-hepatectomy liver failure (PHLF) (time frame: On and after the 5th postoperative day). 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 NCT06532214, 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 1 Aug 2024.