Albumin for Hepatocellular Carcinoma

Phase 3

• Conditions: Hepatocellular Carcinoma; Hypoproteinemia
• Interventions: Drug: Albumin infusion

• Registration Number: NCT03974074
• Lead Sponsor: Guangxi Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-05-30
• Study First Submitted QC: 2019-06-02
• Study First Posted: 2019-06-04
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-22
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Albumin infusion group	Albumin infusion	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).

Primary Outcome Measures

Name	Time	Method
Serum albumin level	Change from Baseline serum albumin at the fifth and seventh days after resection	Recovery of liver function between the two groups
Serum total bilirubin level	Change from Baseline total bilirubin at the fifth and seventh days after resection	Recovery of liver function between the two groups

Secondary Outcome Measures

Name	Time	Method
Rate of postoperative complications	The first months after resection	The rate of postoperative complications between the two groups were compared
Abdominal girth	Change from Baseline abdominal girth at the fifth and seventh days after resection	Drainage liquid and abdominal girth between the two groups were compared

Trial Locations

Locations (2)

Affiliated Tumor Hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China

Jian-Hong Zhong; 🇨🇳 Nanning, Guangxi, China