Effect of Perioperative Sivelstat Administration for Liver Resection

Liver Diseases Clinical Trial

— KMS  

Official title:

Effect of Perioperative Sivelstat Administration for Liver Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738348
• Other study ID #: ESAR
• Secondary ID: Kochi University
• Status: Completed
• Phase: N/A
• First received: August 18, 2008
• Last updated: June 6, 2012
• Start date: April 2007
• Est. completion date: July 2008

Study information

• Verified date: June 2012
• Source: Kochi University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Education, Culture, Sports, Science and Technology
• Study type: Interventional

Clinical Trial 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.

Description:

Whether the incidence of postoperative morbidities, such as liver failure, renal failure, or congestive heart failure, was reduced by administration of perioperative sivelstat.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Liver Diseases

Intervention

Drug:
• sivelstat
sivelstat sodiumhydrate
• glucose
glucose

Locations

Country	Name	City	State
Japan	Kochi Medical School	Kohasu-Okocho, Nankoku

Sponsors (1)

Lead Sponsor	Collaborator
Kochi University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		during hospitalization	Yes
Secondary	The duration of ICU stay and hospital stay, postoperative complications, and the liver damage at 6 POD, measuring hepato-biliary enzyme		during hospitalization	Yes