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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05970159

Acronym

REAL

Enrollment

480

Registered

2023-08-01

Start date

2023-08-31

Completion date

2025-03-31

Last updated

2023-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma, Albumin, Hepatectomy, Liver transplantation, Postoperative outcomes

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Mortality	up to 2 weeks	Death occurring during the postoperative hospital stay.

Other

Measure	Time frame	Description
Days of hospital stay	up to 2 weeks	The length of stay in hospital after surgery.
Days of ICU stay	up to 4 weeks	The length of stay in ICU after surgery.

Countries

China

Contacts

Primary ContactHuichuan Sun

sun.huichuan@zs-hospital.sh.cn+86-21-64041990

Backup ContactHui Li

lihui0801@foxmail.com+86-21-64041990

Outcome results