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

August 1, 2023 updated by: Shanghai Zhongshan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

480

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Principal Investigator:
          • Huichuan Sun
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 2 weeks

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Collaborators

Takeda

Investigators

  • Principal Investigator: Huichuan Sun, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

July 30, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2023-216

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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