Clinical Retrospective Study Analysis of Postoperative Complications Following Hepatectomy

NCT06532214 | Recruiting DMC

• 1 other identifier: NFEC-2023-245
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

hepatectomy; liver failure; Post-hepatectomy liver failure

Outcome Measures

Primary Outcomes (1)

• 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).

  On and after the 5th postoperative day

Secondary Outcomes (1)

• mortality

  During 30 days after surgery

Study Arms (2)

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.

Diagnostic Test: International Study Group for Liver Surgery (ISGLS)

Liver Cirrhosis/No Liver Cirrhosis

Whether the patient has cirrhosis

Interventions

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

PHLF/NPHLF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent liver resection surgery at the participating centers

You may qualify if:

• \. Patients aged 18-80 years 2.Patients who underwent liver resection surgery at the participating centers

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40630620 DERIVED

MeSH Terms

Conditions

Liver Failure; Liver Diseases

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Digestive System Diseases

Central Study Contacts

Kai Wang

CONTACT

13710574386; kaiwang@smu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: January 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

CN (1)