Clinical trial NCT03974074: Albumin for Hepatocellular Carcinoma
Official title: Albumin Infusion for Patients With Hepatocellular Carcinoma and Hypoproteinemia After Hepatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Hypoproteinemia
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The rate of liver cirrhosis is about 40% to 75% among patients with hepatocellular carcinoma (HCC). Therefore, many patients with HCC were with low serum albumin before and after (especially) hepatic resection. Serum albumin level has been routinely used in clinical practice as a surrogate marker to evaluate nutritional status and liver function. Serum albumin concentration is used as an independent mortality risk predictor in a broad range of clinical and research settings. However, the role of albumin infusion in patients with hepatocellular carcinoma (HCC) after resection is unknown. The present study aimed to investigate the safety and clinical necessity of albumin infusion for HCC patients after hepatic resection.


Eligibility criteria: Inclusion Criteria:

* Body mass index \>18.5;
* Patients with primary hepatocellular carcinoma without any treatments for tumors before resection;
* Hepatocellular carcinoma should be confirmed by histopathology;
* With preserved liver function (Child-Pugh score ≤7) before resection
* ECOG performance score 0 or 1;
* Preoperative serum albumin \>35g/L;
* The level of postoperative serum albumin is between 25-30g/L in the first day after resection.

Exclusion Criteria:

* Patients used albumin before liver resection (\<1 months);
* Plasma was used during or after liver resection;
* Surgery involving the extrahepatic bile duct or gastrointestinal tract.

Primary outcomes:
measure: Serum total bilirubin level
timeFrame: Change from Baseline total bilirubin at the fifth and seventh days after resection
measure: Serum albumin level
timeFrame: Change from Baseline serum albumin at the fifth and seventh days after resection
Secondary outcomes:
measure: Abdominal girth
timeFrame: Change from Baseline abdominal girth at the fifth and seventh days after resection
measure: Rate of postoperative complications
timeFrame: The first months after resection
Other outcomes:
Locations:
city: Nanning
country: China
facility: Affiliated Tumor Hospital of Guangxi Medical University
state: Guangxi
city: Nanning
country: China
facility: Jian-Hong Zhong
state: Guangxi
Study officials:
affiliation: Cancer Hospital of Guangxi Medical University
name: Wei-Zhong Tang, MD
role: STUDY_DIRECTOR
References:
citation: European Association for the Study of the Liver. EASL clinical practice guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis. J Hepatol. 2010 Sep;53(3):397-417. doi: 10.1016/j.jhep.2010.05.004. Epub 2010 Jun 1. No abstract available.
citation: Pericleous M, Sarnowski A, Moore A, Fijten R, Zaman M. The clinical management of abdominal ascites, spontaneous bacterial peritonitis and hepatorenal syndrome: a review of current guidelines and recommendations. Eur J Gastroenterol Hepatol. 2016 Mar;28(3):e10-8. doi: 10.1097/MEG.0000000000000548.