The Effect of Somatostatin for Treatment of Post Hepatectomy Liver Failure (PHLF)

Liver Failure Clinical Trial

Official title:

The Effect of Somatostatin for Treatment of Post Hepatectomy Liver Failure (PHLF)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02882347
• Other study ID #: ED15139
• Status: Recruiting
• Phase: Phase 3
• First received: August 17, 2016
• Last updated: September 9, 2016
• Start date: July 2015

Study information

• Verified date: September 2016
• Source: Korea University Anam Hospital
• Contact: Jae Hyun Han, Dr.
• Phone: 82-2-920-6407
• Email: gelasius1[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Failure

Intervention

Drug:
• Somatostatin

Locations

Country	Name	City	State
Korea, Republic of	Korea university Anam hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Anam Hospital	Pharmbio Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in hospital mortality		up to 4 weeks	No
Secondary	Complication rate		up to 4 weeks	No
Secondary	Time to recovery from PHLF (days)		up to 4 weeks	No