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

Phase 3

• Conditions: Liver Failure
• Interventions: Drug: Somatostatin

• Registration Number: NCT02882347
• Lead Sponsor: Korea University Anam Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-08-24
• Study First Posted: 2016-08-29
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-09
• Last Update Posted: 2016-09-12
• Primary Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
somatostatin group	Somatostatin	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.

Primary Outcome Measures

Name	Time	Method
in hospital mortality	up to 4 weeks

Secondary Outcome Measures

Name	Time	Method
Complication rate	up to 4 weeks
Time to recovery from PHLF (days)	up to 4 weeks

Trial Locations

Locations (1)

Korea university Anam hospital; 🇰🇷 Seoul, Korea, Republic of