Clinical Retrospective Study Analysis of Postoperative Complications Following Hepatectomy

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 Overview

• Status: Recruiting
• Conditions: Liver Failure; Liver Dysfunction
• Intervention / Treatment: Diagnostic test: International Study Group for Liver Surgery (ISGLS)

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: kai wang; Phone Number: 13710574386; Email: kaiwang@smu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital
      • Contact: kai wang; Phone Number: 13710574386; Email: kaiwang@smu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent liver resection surgery at the participating centers

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Exclusion criteria are as follows:

  1. Prior cancer treatments such as transarterial chemoembolization, ablation, or targeted therapy.
  2. Repeat liver resection surgeries.
  3. Presence of other malignancies.
  4. Concurrent end-stage diseases including active infections, respiratory failure, decompensated heart failure, and autoimmune disease exacerbations.
  5. Inadequate clinical data availability in medical records.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); According to the ISGLS criteria, the patient was judged to have liver failure and further analysis
Liver Cirrhosis/No Liver Cirrhosis; Whether the patient has cirrhosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	The patient died postoperatively	During 30 days after surgery

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: liver failure; hepatectomy; Post-hepatectomy liver failure
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Liver Failure; Hepatic Insufficiency; Postoperative Complications
• Other Study ID Numbers: NFEC-2023-245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.