REAL: Impact of Preoperative Serum Albumin Level on Postoperative Outcomes in Chinese HCC Patients Treated With Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Hypoalbuminemia group Patients with hepatocellular carcinoma whose preoperative serum albumin concentration are < 36g/L. |
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| Normal group Patients with hepatocellular carcinoma whose preoperative serum albumin concentration are ≥ 36g/L. |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Mortality [up to 2 weeks]
Death occurring during the postoperative hospital stay.
Other Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who diagnosed with HCC confirmed by histology/cytology or clinically criteria regardless of gender.
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HCC Patients who had received the first hepatectomy or liver transplantation (LT).
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Age ≥18 years at the start date of the hepatectomy or LT.
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HCC patients who had the value of serum albumin within 7 days prior to the surgery.
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HCC patients who had exemption of informed consent.
Exclusion Criteria:
- HCC Patients with extrahepatic metastasis or other malignant tumours.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongshan Hospital, Fudan University | Shanghai | Shanghai | China | 200032 |
Sponsors and Collaborators
- Shanghai Zhongshan Hospital
- Takeda
Investigators
- Principal Investigator: Huichuan Sun, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B2023-216