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

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ClinicalTrials.gov Identifier: NCT02882347
Recruitment Status : Unknown
Verified September 2016 by Jae Hyun Han, Korea University Anam Hospital.
Recruitment status was:  Recruiting
First Posted : August 29, 2016
Last Update Posted : September 12, 2016
Sponsor:
Collaborator:
Pharmbio Korea Co., Ltd.
Information provided by (Responsible Party):
Jae Hyun Han, 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.


Condition or disease Intervention/treatment Phase
Liver Failure Drug: Somatostatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Somatostatin for Treatment of Post Hepatectomy Liver Failure (PHLF)
Study Start Date : July 2015
Estimated Primary Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Somatostatin



Primary Outcome Measures :
  1. in hospital mortality [ Time Frame: up to 4 weeks ]

Secondary Outcome Measures :
  1. Complication rate [ Time Frame: up to 4 weeks ]
  2. Time to recovery from PHLF (days) [ Time Frame: up to 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02882347


Contacts
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Contact: Jae Hyun Han, Dr. 82-2-920-6407 gelasius1@naver.com
Contact: Dong-Sik Kim, Professor 82-2-920-6620 kimds1@korea.ac.kr

Locations
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Korea, Republic of
Korea university Anam hospital Recruiting
Seoul, Korea, Republic of, 90248
Contact: Jae Han, Dr    82-2-920-6407    gelasius1@naver.com   
Principal Investigator: Jae Han, Dr         
Sponsors and Collaborators
Korea University Anam Hospital
Pharmbio Korea Co., Ltd.
Investigators
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Study Chair: Dong-Sik Kim, Professor Department of surgery, Korea university Anam hospital

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Responsible Party: Jae Hyun Han, clinical assistant professor, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT02882347     History of Changes
Other Study ID Numbers: ED15139
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: September 12, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs