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Completed

NCT Number: NCT00738348

Effect of Perioperative Sivelstat Administration for Liver Resection

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.

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Key information

Conditions

Liver Diseases Digestive System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kochi Medical School

Kohasu-Okocho, Nankoku, 783-8505, Japan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sivelstat

Drug

sivelstat sodiumhydrate

Other names: sivelstat sodiumhydrate, ONO PHARMACEUTICAL CO

Glucose

Drug

glucose

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kochi University

Other

Registry information

Acronym: KMS

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 20, 2008
Registry last updated
Jun 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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