Albumin for Hepatocellular Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Albumin Infusion in Inpatients With Decompensated Cirrhosis

NCT05719051

Decompensated Cirrhosis Acute-On-Chronic Liver Failure

UNKNOWN

Effects of Maintaining Steady Albumin Levels (TAT 4) on Survival and Liver Related Complications in Cirrhosis With Ascites

NCT04058613

Liver Cirrhosis

UNKNOWN NA

Efficacy of High Dose Albumin Therapy in Improving Liver Transplant-free Survival in Patients With Acute Decompensation of Cirrhosis

NCT05956197

Decompensated Cirrhosis

UNKNOWN

Recombinant Human Serum Albumin in Patients With Liver Cirrhosis and Ascites Subjects

NCT05249374

Hepatic Ascites

COMPLETED PHASE1

Phase II/III of Recombinant Human Albumin Injection

NCT06411743

Hepatic Ascites

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma Hypoproteinemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

Albumin infusion

Intervention Type DRUG

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

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Albumin infusion

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes