Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy (NEIE)

Yokohama City University Medical Center

Status: Completed

Conditions: Esophageal Cancer

Treatments: Drug: sivelestat sodium hydrate

Study type: Interventional

Funder types: Other

Identifiers

NCT01170845

531

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 31 patients

Sex: All

Ages: 55 to 77 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: sivelestat sodium hydrate

S group

Active Comparator group

Description:

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

Treatment:

Drug: sivelestat sodium hydrate