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Albumin for Hepatocellular Carcinoma

NCT03974074 — Phase 3, Unknown, 200 participants, Guangxi Medical University
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Albumin Infusion for Patients With Hepatocellular Carcinoma and Hypoproteinemia After Hepatectomy

RegistryNCT03974074
StatusUnknown
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment200 (Estimated)
SponsorGuangxi Medical University (Other)
ConditionsHepatocellular Carcinoma, Hypoproteinemia
InterventionsAlbumin infusion (Drug)
Datesstart 2019-03-01, primary completion 2020-12-31 (estimated), completion 2020-12-31 (estimated), first posted 2019-06-04, last updated 2020-07-22
Locations2 sites in China

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Albumin infusion groupExperimentalDrug: Albumin infusionAlbumin 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).
Empty controlNo interventionConventional 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).
  • Albumin infusion (Drug): Albumin infusion (20 g, ivgtt, qd) will be performed to patients with HCC after resection in 24 h for three days.

+Outcome measures

Primary outcomes

  • Serum total bilirubin level [Change from Baseline total bilirubin at the fifth and seventh days after resection]: Recovery of liver function between the two groups
  • Serum albumin level [Change from Baseline serum albumin at the fifth and seventh days after resection]: Recovery of liver function between the two groups

Secondary outcomes

  • Abdominal girth [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 [The first months after resection]: The rate of postoperative complications between the two groups were compared

+Eligibility

Sex: All, ages: 18 Years to 75 Years, accepts 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.

+Locations (2)

FacilityCityCountryStatus
Affiliated Tumor Hospital of Guangxi Medical UniversityNanning, GuangxiChinaRecruiting
Jian-Hong ZhongNanning, GuangxiChinaNot yet recruiting

+Publications

  • Results publication: 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
  • Results publication: 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

+Investigators

My Notes