Clinical trial NCT05970159: Impact of Preoperative Serum Albumin Level on Postoperative Outcomes in Chinese HCC Patients Treated With Surgery
Official title: The Impacts of preopeRative sErum Albumin Levels on Postoperative Outcomes in Chinese HCC Patients Treated With Surgical Operation: REAL Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
Albumin
Hepatectomy
Liver transplantation
Postoperative outcomes
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2023-08-01
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Postoperative complications
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Mortality
timeFrame: up to 2 weeks
Other outcomes:
measure: Days of hospital stay
timeFrame: up to 2 weeks
measure: Days of ICU stay
timeFrame: up to 4 weeks
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Huichuan Sun
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.suronc.2017.08.007. Epub 2017 Sep 9.
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 database. Ann Surg. 2004 Oct;240(4):698-708; discussion 708-10. doi: 10.1097/01.sla.0000141195.66155.0c.