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

Hepatocellular Carcinoma Clinical Trial

— REAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05970159
• Other study ID #: B2023-216
• Status: Recruiting
• Start date: August 2023
• Est. completion date: March 2025

Study information

• Verified date: July 2023
• Source: Shanghai Zhongshan Hospital
• Contact: Huichuan Sun
• Phone: +86-21-64041990
• Email: sun.huichuan[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: March 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Takeda

Country where clinical trial is conducted

China, 

References & Publications (2)

Ma KW, Cheung TT, She WH, Chok KSH, Chan ACY, Dai WC, Lo CM. Risk prediction model for major complication after hepatectomy for malignant tumour - A validated scoring system from a university center. Surg Oncol. 2017 Dec;26(4):446-452. doi: 10.1016/j.suro — View Citation

Poon RT, Fan ST, Lo CM, Liu CL, Lam CM, Yuen WK, Yeung C, Wong J. Improving perioperative outcome expands the role of hepatectomy in management of benign and malignant hepatobiliary diseases: analysis of 1222 consecutive patients from a prospective databa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Days of hospital stay	The length of stay in hospital after surgery.	up to 2 weeks
Other	Days of ICU stay	The length of stay in ICU after surgery.	up to 4 weeks
Primary	Postoperative complications	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	Mortality	Death occurring during the postoperative hospital stay.	up to 2 weeks