NCT02882347

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Last Updated

September 12, 2016

Status Verified

September 1, 2016

Enrollment Period

2 years

First QC Date

August 17, 2016

Last Update Submit

September 9, 2016

Conditions

Liver Failure

Outcome Measures

Primary Outcomes (1)

  • in hospital mortality

    up to 4 weeks

Secondary Outcomes (2)

  • Complication rate

    up to 4 weeks

  • Time to recovery from PHLF (days)

    up to 4 weeks

Study Arms (1)

somatostatin group

EXPERIMENTAL

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.

Drug: Somatostatin

Interventions

SomatostatinDRUG
somatostatin group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with PHLF without regard primary disease.
  • Ability to provide written informed consent

You may not qualify if:

  • Concomitant surgery for another intraabdominal organs.
  • Severe renal disease requiring dialysis.
  • Patients with coagulation disorders or taking warfarin.
  • Immunosuppressed patients or the patients with autoimmune disorders.
  • Women with pregnant, breast-feeding.
  • Hypersensitivity to somatostatin.
  • Patients treated with other investigational product within 30 days at the consents are obtained.
  • Patients with a significantly reduced cognitive abilities.
  • Not eligible to participate for study at the discretion of investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea university Anam hospital

Seoul, Seoul, 90248, South Korea

RECRUITING

MeSH Terms

Conditions

Liver Failure

Interventions

Somatostatin

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPancreatic HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Dong-Sik Kim, Professor

    Department of surgery, Korea university Anam hospital

    STUDY CHAIR

Central Study Contacts

Jae Hyun Han, Dr.

CONTACT

82-2-920-6407gelasius1@naver.com

Dong-Sik Kim, Professor

CONTACT

82-2-920-6620kimds1@korea.ac.kr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical assistant professor

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 29, 2016

Study Start

July 1, 2015

Primary Completion

July 1, 2017

Last Updated

September 12, 2016

Record last verified: 2016-09

Locations

KR(1)