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Effect of Perioperative Sivelstat Administration for Liver Resection (KMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00738348
Recruitment Status : Completed
First Posted : August 20, 2008
Last Update Posted : June 8, 2012
Information provided by (Responsible Party):
Takehiro Okabayashi, Kochi University

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.

Condition or disease Intervention/treatment Phase
Liver Diseases Drug: sivelstat Drug: glucose Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Perioperative Sivelstat Administration for Liver Resection
Study Start Date : April 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : July 2008

Arm Intervention/treatment
Active Comparator: 2
250mL of 5% glucose plus 300mg of sivelstat was infected through the vein at 10mL per an hour
Drug: sivelstat
sivelstat sodiumhydrate
Other Name: sivelstat sodiumhydrate, ONO PHARMACEUTICAL CO

Placebo Comparator: 1
250mL of 5% glucose was injected though the vein at 10mL per an hour
Drug: glucose

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT00738348

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Kochi Medical School
Kohasu-Okocho, Nankoku, Japan, 783-8505
Sponsors and Collaborators
Kochi University
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Study Director: Takehiro Okabayashi, MD, PhD Kochi Medical School

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Responsible Party: Takehiro Okabayashi, University, Kochi University Identifier: NCT00738348     History of Changes
Other Study ID Numbers: ESAR
Kochi University
First Posted: August 20, 2008    Key Record Dates
Last Update Posted: June 8, 2012
Last Verified: June 2012
Keywords provided by Takehiro Okabayashi, Kochi University:
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases