Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy

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

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-03-31

Brief Summary

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A neutrophil elastase inhibitor may have effect on suppression of the lung injury after thoransthoracic esophagectomy. The investigators hypothesized that postoperative complication, particularly respiratory complication may be reduced by neutrophil elastase inhibitor after esophagectomy.

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Detailed Description

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The aim of this study was to clarify the usefulness of perioperative administration of sivelestat sodium hydrate, a selective inhibitor of neutrophil elastase in the pulmonary function, systemic inflammatory response, and the postoperative clinical course following video-assisted thoracoscopic esohpagectomy for esophageal cancer.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

Patients in the control group received saline for 7 days starting at the beginning of surgery

Group Type PLACEBO_COMPARATOR

sivelestat sodium hydrate

Intervention Type DRUG

saline or sivelestat sodium hydrate intravenously for 7 days starting the beginning of surgery

S group

Patients in the S group received sivelestat sodium hydrate at a dosage 4.8mg/kg/day for 7 days starting at the beginning of surgery

Group Type ACTIVE_COMPARATOR

sivelestat sodium hydrate

Intervention Type DRUG

saline or sivelestat sodium hydrate intravenously for 7 days starting the beginning of surgery

Interventions

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sivelestat sodium hydrate

saline or sivelestat sodium hydrate intravenously for 7 days starting the beginning of surgery

Intervention Type DRUG

Other Intervention Names

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Elaspol

Eligibility Criteria

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Inclusion Criteria

* Thoracic esophageal squamous cell carcinoma

Exclusion Criteria

* Preoperative chemoradiotherapy
* Cardiovascular disease with NYHA grade III or IV
* Pulmonary disorder with Hugh-Jones classification II, III, IV, or V, preo
* Liver cirrhosis
* Renal failure

Minimum Eligible Age

55 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No