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Trial Title:
Impact of Preoperative Serum Albumin Level on Postoperative Outcomes in Chinese HCC Patients Treated With Surgery
NCT ID:
NCT05970159
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma, Hepatocellular
Conditions: Keywords:
Hepatocellular carcinoma
Albumin
Hepatectomy
Liver transplantation
Postoperative outcomes
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
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.
Criteria for eligibility:
Study pop:
All patients who met the criteria for inclusion in this real-world study from Zhongshan
Hospital, Fudan University will be included. According to a preliminary feasibility
department investigation, a sample size of approximately 480 subjects will be enrolled in
this study.
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongshan Hospital, Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Li
Phone:
+86-21-64041990
Email:
lihui0801@foxmail.com
Investigator:
Last name:
Huichuan Sun
Email:
Principal Investigator
Start date:
August 2023
Completion date:
March 2025
Lead sponsor:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Collaborator:
Agency:
Takeda
Agency class:
Industry
Source:
Shanghai Zhongshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05970159
