Effect of Perioperative Sivelstat Administration for Liver Resection (KMS)

Kochi University

Status: Completed

Conditions: Liver Diseases

Treatments: Drug: sivelstat; Drug: glucose

Study type: Interventional

Funder types: Other

Identifiers

NCT00738348

Kochi University

ESAR

Details and patient eligibility

About

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.

Full description

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

Enrollment: 50 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

2

Active Comparator group

Description:

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

Treatment:

Drug: sivelstat

1

Placebo Comparator group

Description:

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

Treatment:

Drug: glucose