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出境医 / 临床实验 / Albumin for Hepatocellular Carcinoma

Albumin for Hepatocellular Carcinoma

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.

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

Study Design
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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, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
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).
Outcome Measures
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


Eligibility Criteria
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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.
Contacts and Locations

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

Locations
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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
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Study Director: Wei-Zhong Tang, MD Cancer Hospital of Guangxi Medical University
Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date July 22, 2020
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2019)
  • 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
  • Rate of postoperative complications [ Time Frame: The first months after resection ]
    The rate of postoperative complications between the two groups were compared
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Albumin for Hepatocellular Carcinoma
Official Title  ICMJE Albumin Infusion for Patients With Hepatocellular Carcinoma and Hypoproteinemia After Hepatectomy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatocellular Carcinoma
  • Hypoproteinemia
Intervention  ICMJE Drug: Albumin infusion
Albumin infusion (20 g, ivgtt, qd) will be performed to patients with HCC after resection in 24 h for three days.
Study Arms  ICMJE
  • 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).
    Intervention: Drug: Albumin infusion
  • 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).
Publications *
  • 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. Review.
  • 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 2, 2019) 		200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jian-Hong Zhong, PdD 771 5330855 zhongjianhong@gxmu.edu.cn
Contact: Bang-De Xiang, PdD xiangbangde@gxmu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03974074
Other Study ID Numbers  ICMJE Alb-HCC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jian-Hong Zhong, Guangxi Medical University
Study Sponsor  ICMJE Guangxi Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wei-Zhong Tang, MD Cancer Hospital of Guangxi Medical University
PRS Account Guangxi Medical University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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