Albumin for Hepatocellular Carcinoma

Guangxi Medical University

Status and phase: Unknown; Phase 3

Conditions: Hypoproteinemia; Hepatocellular Carcinoma

Treatments: Drug: Albumin infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03974074

Alb-HCC

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 2 patient groups

Albumin infusion group

Experimental group

Description:

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).

Treatment:

Drug: Albumin infusion

Empty control

No Intervention group

Description:

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).