Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy

Esophageal Cancer Clinical Trial

— NEIE  

Official title:

A Pilot Study of Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01170845
• Other study ID #: 531
• Status: Completed
• Phase: N/A
• First received: July 23, 2010
• Last updated: July 26, 2010
• Start date: March 2007
• Est. completion date: March 2009

Study information

• Verified date: March 2007
• Source: Yokohama City University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 77 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Lung Injury

Intervention

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

Locations

Country	Name	City	State
Japan	Chikara Kunisaki	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Yokohama City University Medical Center

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function	the arterial oxygen pressure	9 days	No
Secondary	Pulmonary function	fraction of inspired oxygen ratio (PF ratio)	9 days	No
Secondary	Pulmonary function	the duration of mechanical ventilation	9 days	No