Effect of Perioperative Sivelstat Administration for Liver Resection - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 18, 2008

Last Updated Date

August 19, 2008

Start Date ^†

April 2007

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00738348 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Effect of Perioperative Sivelstat Administration for Liver Resection

Official Title ^†

Effect of Perioperative Sivelstat Administration for Liver Resection

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 Phase

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Liver Diseases

Intervention ^†

Drug: sivelstat
Drug: glucose

Study Arms / Comparison Groups

Active Comparator: 250mL of 5% glucose plus 300mg of sivelstat was infected through the vein at 10mL per an hour
Placebo Comparator: 250mL of 5% glucose was injected though the vein at 10mL per an hour

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

July 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Japan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00738348

Responsible Party

Kochi Medical School, Kochi University

Secondary IDs ^††

Kochi University

Study Sponsor ^†

Kochi University

Collaborators ^††

Investigators ^†

Study Director:

Takehiro Okabayashi, MD, PhD

Kochi Medical School

Information Provided By

Kochi University

Verification Date

August 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.