Albumin for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Albumin Infusion for Patients With Hepatocellular Carcinoma and Hypoproteinemia After Hepatectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03974074
• Other study ID #: Alb-HCC
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2020
• Source: Guangxi Medical University
• Contact: Jian-Hong Zhong, PdD
• Phone: 771 5330855
• Email: zhongjianhong[@]gxmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Hypoproteinemia

Intervention

Drug:
• Albumin infusion
Albumin infusion (20 g, ivgtt, qd) will be performed to patients with HCC after resection in 24 h for three days.

Locations

Country	Name	City	State
China	Affiliated Tumor Hospital of Guangxi Medical University	Nanning	Guangxi
China	Jian-Hong Zhong	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum total bilirubin level	Recovery of liver function between the two groups	Change from Baseline total bilirubin at the fifth and seventh days after resection
Primary	Serum albumin level	Recovery of liver function between the two groups	Change from Baseline serum albumin at the fifth and seventh days after resection
Secondary	Abdominal girth	Drainage liquid and abdominal girth between the two groups were compared	Change from Baseline abdominal girth at the fifth and seventh days after resection
Secondary	Rate of postoperative complications	The rate of postoperative complications between the two groups were compared	The first months after resection