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Albumin for Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma, Hypoproteinemia

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Albumin infusion
Sponsored by
Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Affiliated Tumor Hospital of Guangxi Medical UniversityRecruiting
  • Jian-Hong Zhong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Albumin infusion group

Empty control

Arm 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).

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).

Outcomes

Primary Outcome Measures

Serum total bilirubin level
Recovery of liver function between the two groups
Serum albumin level
Recovery of liver function between the two groups

Secondary Outcome Measures

Abdominal girth
Drainage liquid and abdominal girth between the two groups were compared
Rate of postoperative complications
The rate of postoperative complications between the two groups were compared

Full Information

First Posted
May 30, 2019
Last Updated
July 21, 2020
Sponsor
Guangxi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03974074
Brief Title
Albumin for Hepatocellular Carcinoma
Official Title
Albumin Infusion for Patients With Hepatocellular Carcinoma and Hypoproteinemia After Hepatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangxi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Hypoproteinemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Albumin infusion group
Arm Type
Experimental
Arm 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).
Arm Title
Empty control
Arm Type
No Intervention
Arm 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).
Intervention Type
Drug
Intervention Name(s)
Albumin infusion
Intervention Description
Albumin infusion (20 g, ivgtt, qd) will be performed to patients with HCC after resection in 24 h for three days.
Primary Outcome Measure Information:
Title
Serum total bilirubin level
Description
Recovery of liver function between the two groups
Time Frame
Change from Baseline total bilirubin at the fifth and seventh days after resection
Title
Serum albumin level
Description
Recovery of liver function between the two groups
Time Frame
Change from Baseline serum albumin at the fifth and seventh days after resection
Secondary Outcome Measure Information:
Title
Abdominal girth
Description
Drainage liquid and abdominal girth between the two groups were compared
Time Frame
Change from Baseline abdominal girth at the fifth and seventh days after resection
Title
Rate of postoperative complications
Description
The rate of postoperative complications between the two groups were compared
Time Frame
The first months after resection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian-Hong Zhong, PdD
Phone
771 5330855
Email
zhongjianhong@gxmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Bang-De Xiang, PdD
Email
xiangbangde@gxmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Zhong Tang, MD
Organizational Affiliation
Cancer Hospital of Guangxi Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Affiliated Tumor Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian-Hong Zhong, PdD
Email
zhongjianhong@gxmu.edu.cn
Facility Name
Jian-Hong Zhong
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian-Hong Zhong
Phone
771 5330855
Email
zhongjianhong@gxmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20633946
Citation
European Association for the Study of the Liver. EASL clinical practice guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis. J Hepatol. 2010 Sep;53(3):397-417. doi: 10.1016/j.jhep.2010.05.004. Epub 2010 Jun 1. No abstract available.
Results Reference
result
PubMed Identifier
26671516
Citation
Pericleous M, Sarnowski A, Moore A, Fijten R, Zaman M. The clinical management of abdominal ascites, spontaneous bacterial peritonitis and hepatorenal syndrome: a review of current guidelines and recommendations. Eur J Gastroenterol Hepatol. 2016 Mar;28(3):e10-8. doi: 10.1097/MEG.0000000000000548.
Results Reference
result

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Albumin for Hepatocellular Carcinoma

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