Albumin for Hepatocellular Carcinoma

Albumin Infusion for Patients With Hepatocellular Carcinoma and Hypoproteinemia After Hepatectomy

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.

Study Overview

• Status: Unknown
• Conditions: Hepatocellular Carcinoma; Hypoproteinemia
• Intervention / Treatment: Drug: Albumin infusion

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jian-Hong Zhong, PdD; Phone Number: 771 5330855; Email: zhongjianhong@gxmu.edu.cn
• Study Contact Backup: Name: Bang-De Xiang, PdD; Email: xiangbangde@gxmu.edu.cn

Study Locations

• China
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Recruiting
      • Affiliated Tumor Hospital of Guangxi Medical University
      • Contact: Jian-Hong Zhong, PdD; Email: zhongjianhong@gxmu.edu.cn
    • Nanning, Guangxi, China, 530021
      • Not yet recruiting
      • Jian-Hong Zhong
      • Contact: Jian-Hong Zhong; Phone Number: 771 5330855; Email: zhongjianhong@gxmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Albumin infusion group; Albumin infusion (20 g, ivgtt, qd) will be performed to patients with HCC after hepatic resection in 24 h for three days. All patients wil receive furosemide (10 mg, iv) after albumin transfusion. In the fifth day after resection, patients will receive albumin transfusion if they have ascites with shifting dullness, moderate edema (below both lower ankle joints) with serum albumin lower than 30 g/L, severe postoperation complication (septicopyemia, postoperative bleeding with reoperation, or biliary fistula).	Drug: Albumin infusion; Albumin infusion (20 g, ivgtt, qd) will be performed to patients with HCC after resection in 24 h for three days.
No Intervention: Empty control; Conventional liver protection and rehydration therapy.In the fifth day after resection, patients will receive albumin transfusion if they have ascites with shifting dullness, moderate edema (below both lower ankle joints) with serum albumin lower than 30 g/L, severe postoperation complication (septicopyemia, postoperative bleeding with reoperation, or biliary fistula).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Rate of postoperative complications	The rate of postoperative complications between the two groups were compared	The first months after resection

Collaborators and Investigators

• Sponsor: Guangxi Medical University
• Investigators: Study Director: Wei-Zhong Tang, MD, Cancer Hospital of Guangxi Medical University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: June 2, 2019
• First Posted (Actual): June 4, 2019

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Hematologic Diseases; Digestive System Neoplasms; Liver Diseases; Blood Protein Disorders; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Hypoproteinemia
• Other Study ID Numbers: Alb-HCC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No