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

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Fudan University

Status

Enrolling

Conditions

Hepatocellular Carcinoma

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT05970159
B2023-216

Details and patient eligibility

About

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.

Full 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.

Enrollment

480 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

480 participants in 2 patient groups

Hypoalbuminemia group
Description:
Patients with hepatocellular carcinoma whose preoperative serum albumin concentration are < 36g/L.
Normal group
Description:
Patients with hepatocellular carcinoma whose preoperative serum albumin concentration are ≥ 36g/L.

Trial contacts and locations

1

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Central trial contact

Huichuan Sun; Hui Li

Data sourced from clinicaltrials.gov

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