Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Albumin for Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03974074
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Jian-Hong Zhong, 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Hypoproteinemia Drug: Albumin infusion Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Albumin Infusion for Patients With Hepatocellular Carcinoma and Hypoproteinemia After Hepatectomy
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 31, 2020

Arm Intervention/treatment
Experimental: 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).
Drug: Albumin infusion
Albumin infusion (20 g, ivgtt, qd) will be performed to patients with HCC after resection in 24 h for three days.

No Intervention: 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).



Primary Outcome Measures :
  1. Serum total bilirubin level [ Time Frame: Change from Baseline total bilirubin at the fifth and seventh days after resection ]
    Recovery of liver function between the two groups

  2. Serum albumin level [ Time Frame: Change from Baseline serum albumin at the fifth and seventh days after resection ]
    Recovery of liver function between the two groups


Secondary Outcome Measures :
  1. Abdominal girth [ Time Frame: Change from Baseline abdominal girth at the fifth and seventh days after resection ]
    Drainage liquid and abdominal girth between the two groups were compared

  2. Rate of postoperative complications [ Time Frame: The first months after resection ]
    The rate of postoperative complications between the two groups were compared



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974074


Contacts
Layout table for location contacts
Contact: Jian-Hong Zhong, PdD 771 5330855 zhongjianhong@gxmu.edu.cn
Contact: Bang-De Xiang, PdD xiangbangde@gxmu.edu.cn

Locations
Layout table for location information
China, Guangxi
Affiliated Tumor Hospital of Guangxi Medical University Recruiting
Nanning, Guangxi, China, 530021
Contact: Jian-Hong Zhong, PdD       zhongjianhong@gxmu.edu.cn   
Jian-Hong Zhong Not yet recruiting
Nanning, Guangxi, China, 530021
Contact: Jian-Hong Zhong    771 5330855    zhongjianhong@gxmu.edu.cn   
Sponsors and Collaborators
Guangxi Medical University
Investigators
Layout table for investigator information
Study Director: Wei-Zhong Tang, MD Cancer Hospital of Guangxi Medical University

Publications of Results:
Layout table for additonal information
Responsible Party: Jian-Hong Zhong, Principal Investigator, Guangxi Medical University
ClinicalTrials.gov Identifier: NCT03974074     History of Changes
Other Study ID Numbers: Alb-HCC
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Hepatocellular
Hypoproteinemia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Blood Protein Disorders
Hematologic Diseases