Back to resultsEffect of Perioperative Sivelstat Administration for Liver Resection (KMS)
Primary Purpose
Liver Diseases
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
sivelstat
glucose
Sponsored by
About this trial
This is an interventional prevention trial for Liver Diseases focused on measuring surgery
Eligibility Criteria
Inclusion Criteria:
- liver disease which surgical management was indicated
Exclusion Criteria:
- weight loss greater than 10 per cent during the previous 6 months, signs of distant metastasis, or of respiratory, renal or heart disease
Sites / Locations
- Kochi Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
2
1
Arm Description
250mL of 5% glucose plus 300mg of sivelstat was infected through the vein at 10mL per an hour
250mL of 5% glucose was injected though the vein at 10mL per an hour
Outcomes
Primary Outcome Measures
The incidence of liver damage due to reperfusion injury by Pringle maneuver was measured by several cytokines, including IL-8, IL-6, and HMGB-1.
Secondary Outcome Measures
The duration of ICU stay and hospital stay, postoperative complications, and the liver damage at 6 POD, measuring hepato-biliary enzyme
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00738348
Brief Title
Effect of Perioperative Sivelstat Administration for Liver Resection
Acronym
KMS
Official Title
Effect of Perioperative Sivelstat Administration for Liver Resection
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kochi University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
It is reported that sivelstat improved and preserved the postoperative renal function in the orthopedic management. Moreover because sivelstat reduced the migration of neutrophil, it improved acute lung injury. During liver resection, Pringle maneuver, clamping the hepatoduodenal ligament, was performed. Pringle maneuver causes reperfusion injury of the liver. We have a hypothesis that sivelstat prevent the warm shock of reperfusion injury of the liver by Pringle maneuver.
Detailed Description
Whether the incidence of postoperative morbidities, such as liver failure, renal failure, or congestive heart failure, was reduced by administration of perioperative sivelstat.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases
Keywords
surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Description
250mL of 5% glucose plus 300mg of sivelstat was infected through the vein at 10mL per an hour
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
250mL of 5% glucose was injected though the vein at 10mL per an hour
Intervention Type
Drug
Intervention Name(s)
sivelstat
Other Intervention Name(s)
sivelstat sodiumhydrate, ONO PHARMACEUTICAL CO
Intervention Description
sivelstat sodiumhydrate
Intervention Type
Drug
Intervention Name(s)
glucose
Intervention Description
glucose
Primary Outcome Measure Information:
Title
The incidence of liver damage due to reperfusion injury by Pringle maneuver was measured by several cytokines, including IL-8, IL-6, and HMGB-1.
Time Frame
during hospitalization
Secondary Outcome Measure Information:
Title
The duration of ICU stay and hospital stay, postoperative complications, and the liver damage at 6 POD, measuring hepato-biliary enzyme
Time Frame
during hospitalization
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
liver disease which surgical management was indicated
Exclusion Criteria:
weight loss greater than 10 per cent during the previous 6 months, signs of distant metastasis, or of respiratory, renal or heart disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takehiro Okabayashi, MD, PhD
Organizational Affiliation
Kochi Medical School
Official's Role
Study Director
Facility Information:
Facility Name
Kochi Medical School
City
Kohasu-Okocho, Nankoku
ZIP/Postal Code
783-8505
Country
Japan
12. IPD Sharing Statement
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Effect of Perioperative Sivelstat Administration for Liver Resection
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