Clinical Trials/NCT00738348

NCT00738348CompletedNot Applicable

Effect of Perioperative Sivelstat Administration for Liver Resection

Kochi University1 site in 1 country50 target enrollmentStarted: April 2007Last updated: June 8, 2012

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor: Kochi University
Enrollment: 50
Locations: 1
Primary Endpoint: 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.

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Single Group
Primary Purpose: Prevention
Masking: Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Sex: 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

Arms & Interventions

2

Active Comparator

250mL of 5% glucose plus 300mg of sivelstat was infected through the vein at 10mL per an hour

Intervention: sivelstat (Drug)

1

Placebo Comparator

250mL of 5% glucose was injected though the vein at 10mL per an hour

Intervention: glucose (Drug)

Outcomes

Primary Outcomes

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 Outcomes

The duration of ICU stay and hospital stay, postoperative complications, and the liver damage at 6 POD, measuring hepato-biliary enzyme(during hospitalization)

Investigators

Sponsor

Kochi University

Sponsor Class

Other

Responsible Party

Principal Investigator

Takehiro Okabayashi

University

Kochi University

Study Sites (1)

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