The Effect of Somatostatin for Treatment of Post Hepatectomy Liver Failure (PHLF)
|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- in hospital mortality [ Time Frame: up to 4 weeks ]
- Complication rate [ Time Frame: up to 4 weeks ]
- Time to recovery from PHLF (days) [ Time Frame: up to 4 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02882347
|Contact: Jae Hyun Han, Dr.||firstname.lastname@example.org|
|Contact: Dong-Sik Kim, Professoremail@example.com|
|Korea, Republic of|
|Korea university Anam hospital||Recruiting|
|Seoul, Korea, Republic of, 90248|
|Contact: Jae Han, Dr 82-2-920-6407 firstname.lastname@example.org|
|Principal Investigator: Jae Han, Dr|
|Study Chair:||Dong-Sik Kim, Professor||Department of surgery, Korea university Anam hospital|