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Effect of Perioperative Sivelstat Administration for Liver Resection

NCT ID: NCT00738348

Last Updated: 2012-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-07-31

Brief Summary

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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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Detailed Description

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

Conditions

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Liver Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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2

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

Group Type ACTIVE_COMPARATOR

sivelstat

Intervention Type DRUG

sivelstat sodiumhydrate

1

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

Group Type PLACEBO_COMPARATOR

glucose

Intervention Type DRUG

glucose

Interventions

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sivelstat

sivelstat sodiumhydrate

Intervention Type DRUG

glucose

glucose

Intervention Type DRUG

Other Intervention Names

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sivelstat sodiumhydrate, ONO PHARMACEUTICAL CO

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kochi University

OTHER

Sponsor Role lead

Responsible Party

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Takehiro Okabayashi

University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Takehiro Okabayashi, MD, PhD

Role: STUDY_DIRECTOR

Kochi Medical School

Locations

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Kochi Medical School

Kohasu-Okocho, Nankoku, , Japan

Site Status

Countries

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Japan

Other Identifiers

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Kochi University

Identifier Type: -

Identifier Source: secondary_id

ESAR

Identifier Type: -

Identifier Source: org_study_id

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