The Effect of Somatostatin for Treatment of Post Hepatectomy Liver Failure (PHLF)
Primary Purpose
Liver Failure
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Somatostatin
Sponsored by
About this trial
This is an interventional treatment trial for Liver Failure
Eligibility Criteria
Inclusion Criteria:
- Patients with PHLF without regard primary disease.
- Ability to provide written informed consent
Exclusion Criteria:
- 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.
Sites / Locations
- Korea university Anam hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
somatostatin group
Arm Description
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.
Outcomes
Primary Outcome Measures
in hospital mortality
Secondary Outcome Measures
Complication rate
Time to recovery from PHLF (days)
Full Information
NCT ID
NCT02882347
First Posted
August 17, 2016
Last Updated
September 9, 2016
Sponsor
Korea University Anam Hospital
Collaborators
Pharmbio Korea Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02882347
Brief Title
The Effect of Somatostatin for Treatment of Post Hepatectomy Liver Failure (PHLF)
Official Title
The Effect of Somatostatin for Treatment of Post Hepatectomy Liver Failure (PHLF)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Anam Hospital
Collaborators
Pharmbio Korea Co., Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
somatostatin group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Somatostatin
Primary Outcome Measure Information:
Title
in hospital mortality
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
Complication rate
Time Frame
up to 4 weeks
Title
Time to recovery from PHLF (days)
Time Frame
up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with PHLF without regard primary disease.
Ability to provide written informed consent
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Hyun Han, Dr.
Phone
82-2-920-6407
Email
gelasius1@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dong-Sik Kim, Professor
Phone
82-2-920-6620
Email
kimds1@korea.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Sik Kim, Professor
Organizational Affiliation
Department of surgery, Korea university Anam hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Korea university Anam hospital
City
Seoul
ZIP/Postal Code
90248
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Han, Dr
Phone
82-2-920-6407
Email
gelasius1@naver.com
First Name & Middle Initial & Last Name & Degree
Jae Han, Dr
12. IPD Sharing Statement
Learn more about this trial
The Effect of Somatostatin for Treatment of Post Hepatectomy Liver Failure (PHLF)
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