Albumin for Hepatocellular Carcinoma

NCT03974074 | Unknown Phase 3 DMC

• 1 other identifier: Alb-HCC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatocellular Carcinoma; Hypoproteinemia

Outcome Measures

Primary Outcomes (2)

• Serum total bilirubin level

  Recovery of liver function between the two groups

  Change from Baseline total bilirubin at the fifth and seventh days after resection

• Serum albumin level

  Recovery of liver function between the two groups

  Change from Baseline serum albumin at the fifth and seventh days after resection

Secondary Outcomes (2)

• Abdominal girth

  Change from Baseline abdominal girth at the fifth and seventh days after resection

• Rate of postoperative complications

  The first months after resection

Study Arms (2)

Albumin infusion group

EXPERIMENTAL

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

Empty control

NO INTERVENTION

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).

Interventions

Albumin infusion DRUG

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

Albumin infusion group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangxi Medical University: lead

Study Sites (2)

Affiliated Tumor Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

Jian-Hong Zhong

Nanning, Guangxi, 530021, China

NOT YET RECRUITING

Related Publications (2)

• 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.

  PMID: 20633946 RESULT

• 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.

  PMID: 26671516 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hypoproteinemia

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Wei-Zhong Tang, MD

  Cancer Hospital of Guangxi Medical University

  STUDY DIRECTOR

Central Study Contacts

Jian-Hong Zhong, PdD

CONTACT

771 5330855; zhongjianhong@gxmu.edu.cn

Bang-De Xiang, PdD

CONTACT

xiangbangde@gxmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 4, 2019
• Study Start: March 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)