Albumin for Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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Albumin Infusion for Patients With Hepatocellular Carcinoma and Hypoproteinemia After Hepatectomy

Conditions
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Hepatocellular Carcinoma, Hypoproteinemia

Intervention / Treatment
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* Drug: Albumin infusion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Albumin infusion group<br>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<br>* Albumin infusion (20 g, ivgtt, qd) will be performed to patients with HCC after resection in 24 h for three days.<br>|
| No Intervention: Empty control<br>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?
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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 |