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Albumin for Hepatocellular Carcinoma

Albumin Infusion for Patients With Hepatocellular Carcinoma and Hypoproteinemia After Hepatectomy

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03974074
Enrollment
200
Registered
2019-06-04
Start date
2019-03-01
Completion date
2020-12-31
Last updated
2020-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma, Hypoproteinemia

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.

Interventions

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

Sponsors

Guangxi Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Serum total bilirubin levelChange from Baseline total bilirubin at the fifth and seventh days after resectionRecovery of liver function between the two groups
Serum albumin levelChange from Baseline serum albumin at the fifth and seventh days after resectionRecovery of liver function between the two groups

Secondary

MeasureTime frameDescription
Abdominal girthChange from Baseline abdominal girth at the fifth and seventh days after resectionDrainage liquid and abdominal girth between the two groups were compared
Rate of postoperative complicationsThe first months after resectionThe rate of postoperative complications between the two groups were compared

Countries

China

Contacts

Primary ContactJian-Hong Zhong, PdD
zhongjianhong@gxmu.edu.cn771 5330855
Backup ContactBang-De Xiang, PdD
xiangbangde@gxmu.edu.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026