Impact of Preoperative Serum Albumin Level on Postoperative Outcomes in Chinese HCC Patients Treated With Surgery

Recruiting

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT05970159
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

This is an observational and retrospective cohort study to evaluate the impact of the preoperative serum albumin concentration on postoperative outcomes among hepatocellular carcinoma (HCC) patients who received hepatectomy or liver transplantation.

Detailed Description

The impact of hypoalbuminemia on postoperative outcomes has been the subject of several investigations which agreed that hypoalbuminemia is an important risk factor for mortality and morbidity after various types of surgical operations. Unfortunately, there are limited real-world data to establish the correlation between hypoalbuminemia and hepatectomy or liver transplantation postoperative complications in China. This study will evaluate the impact of the preoperative serum albumin concentration on postoperative outcomes among hepatocellular carcinoma (HCC) patients who received hepatectomy or liver transplantation.

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-07-30
• Study Start: 2023-08
• Study First Posted: 2023-08-01
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-03
• Primary Completion: 2024-06
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

• Patients who diagnosed with HCC confirmed by histology/cytology or clinically criteria regardless of gender.
• HCC Patients who had received the first hepatectomy or liver transplantation (LT).
• Age ≥18 years at the start date of the hepatectomy or LT.
• HCC patients who had the value of serum albumin within 7 days prior to the surgery.
• HCC patients who had exemption of informed consent.

Exclusion Criteria

• HCC Patients with extrahepatic metastasis or other malignant tumours.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative complications	up to 2 weeks	Complications following surgery that occurred during hospitalization. For the hepatectomy cohort of patients, postoperative complications included incision, urinary tract and abdominal infections, pleural fluid, ascites, post-hepatectomy hemorrhage bile leakage, post hepatectomy liver failure, renal insufficiency, multiple organ dysfunction syndrome, pneumonia and pulmonary embolism, etc. For the LT cohort of patients, postoperative complications included primary nonfunction, hemorrhage, hepatic artery thrombosis, hepatic vein thrombosis, bile leakage, acute kidney injury, deep wound infections and catheter-related infections.

Secondary Outcome Measures

Name	Time	Method
Mortality	up to 2 weeks	Death occurring during the postoperative hospital stay.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China