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


N/A
55 Years
77 Years
Not Enrolling
Both
Esophageal Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pulmonary function

Outcome Description:

the arterial oxygen pressure

Outcome Time Frame:

9 days

Safety Issue:

No

Principal Investigator

Chikara Kunisaki, MD,PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Yokohama City University Medical Center

Authority:

Japan: Institutional Review Board

Study ID:

531

NCT ID:

NCT01170845

Start Date:

March 2007

Completion Date:

March 2009

Related Keywords:

  • Esophageal Cancer
  • Esophagectomy
  • Postoperative respiratory complications
  • neutrophil elastase inhibitor
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Lung Injury

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