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Clinical Trials/NCT05970159
NCT05970159
Recruiting
Not Applicable

The Impacts of preopeRative sErum Albumin Levels on Postoperative Outcomes in Chinese HCC Patients Treated With Surgical Operation: REAL Study

Shanghai Zhongshan Hospital1 site in 1 country480 target enrollmentAugust 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hepatocellular Carcinoma
Sponsor
Shanghai Zhongshan Hospital
Enrollment
480
Locations
1
Primary Endpoint
Postoperative complications
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2023
End Date
March 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shanghai Zhongshan Hospital
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Postoperative complications

Time Frame: 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 Outcomes

  • Mortality(up to 2 weeks)

Study Sites (1)

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