Effect of Perioperative Sivelstat Administration for Liver Resection (KMS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takehiro Okabayashi, Kochi University
ClinicalTrials.gov Identifier:
NCT00738348
First received: August 18, 2008
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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 Intervention
Liver Diseases
Drug: sivelstat
Drug: glucose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Perioperative Sivelstat Administration for Liver Resection

Resource links provided by NLM:


Further study details as provided by Kochi University:

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. [ Time Frame: during hospitalization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: April 2007
Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
glucose
Other Name: glucose

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00738348

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

No publications provided

Responsible Party: Takehiro Okabayashi, University, Kochi University
ClinicalTrials.gov Identifier: NCT00738348     History of Changes
Other Study ID Numbers: ESAR, Kochi University
Study First Received: August 18, 2008
Last Updated: June 6, 2012
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Kochi University:
surgery

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 19, 2014