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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Liver Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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somatostatin group

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.

Group Type EXPERIMENTAL

Somatostatin

Intervention Type DRUG

Interventions

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Somatostatin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No