Liver Failure
Conditions
Brief summary
Post hepatectomy liver failure (PHLF) is a serious medical problem could lead to patient death, however, definite treatment strategy has not been established. The liver is a regenerating organ and the possibility of PHLF could be reduced when the appropriate liver regeneration is guaranteed. Portal flow has known to be important during liver regeneration. Low portal flow cannot induce proper regeneration, contrary, excessive flow increase shear stress in the hepatic sinusoid resulting liver failure. Various medications has been used in malignant liver cirrhosis to reduce portal pressure. Among them, somatostatin has been used modulating portal flow reducing portal and sinusoidal pressure. In this study, the investigators administrate somatostatin at a rate of 3.5ug/kg/hour to PHLF patients (prothrombin time \< 50% and serum total bilirubin \> 2.9mg/dl after liver resection) until recovery from liver failure. For assessment of the recovery of liver failure, the investigators evaluate aspartate transaminase (AST), alanine transaminase (ALT), serum total bilirubin and prothrombin time periodically after administration of medication.
Interventions
DRUGSomatostatin
Sponsors
Pharmbio Korea Co., Ltd.
Korea University Anam Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with PHLF without regard primary disease. 2. Ability to provide written informed consent
Exclusion criteria
1. Concomitant surgery for another intraabdominal organs. 2. Severe renal disease requiring dialysis. 3. Patients with coagulation disorders or taking warfarin. 4. Immunosuppressed patients or the patients with autoimmune disorders. 5. Women with pregnant, breast-feeding. 6. Hypersensitivity to somatostatin. 7. Patients treated with other investigational product within 30 days at the consents are obtained. 8. Patients with a significantly reduced cognitive abilities. 9. Not eligible to participate for study at the discretion of investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| in hospital mortality | up to 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Complication rate | up to 4 weeks |
| Time to recovery from PHLF (days) | up to 4 weeks |
Countries
South Korea
Contacts
Primary ContactJae Hyun Han, Dr.
Backup ContactDong-Sik Kim, Professor
Outcome results
None listed