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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01170845
First Posted: July 27, 2010
Last Update Posted: July 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yokohama City University Medical Center
  Purpose
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.

Condition Intervention
Esophageal Cancer Drug: sivelestat sodium hydrate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Pilot Study of Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy

Resource links provided by NLM:


Further study details as provided by Yokohama City University Medical Center:

Primary Outcome Measures:
  • Pulmonary function [ Time Frame: 9 days ]
    the arterial oxygen pressure


Secondary Outcome Measures:
  • Pulmonary function [ Time Frame: 9 days ]
    fraction of inspired oxygen ratio (PF ratio)

  • Pulmonary function [ Time Frame: 9 days ]
    the duration of mechanical ventilation


Enrollment: 31
Study Start Date: March 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control group
Patients in the control group received saline for 7 days starting at the beginning of surgery
Drug: sivelestat sodium hydrate
saline or sivelestat sodium hydrate intravenously for 7 days starting the beginning of surgery
Other Name: Elaspol
Active Comparator: 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
Drug: sivelestat sodium hydrate
saline or sivelestat sodium hydrate intravenously for 7 days starting the beginning of surgery
Other Name: Elaspol

Detailed 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.
  Eligibility

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Ages Eligible for Study:   55 Years to 77 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170845


Locations
Japan
Chikara Kunisaki
Yokohama, Kanagawa, Japan, 232-0024
Sponsors and Collaborators
Yokohama City University Medical Center
Investigators
Study Chair: Chikara Kunisaki, MD,PhD Yokohama City University Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Institutional Review Board, Yokohama City University, Medical Center
ClinicalTrials.gov Identifier: NCT01170845     History of Changes
Other Study ID Numbers: 531
First Submitted: July 23, 2010
First Posted: July 27, 2010
Last Update Posted: July 27, 2010
Last Verified: March 2007

Keywords provided by Yokohama City University Medical Center:
Esophagectomy
Postoperative respiratory complications
neutrophil elastase inhibitor

Additional relevant MeSH terms:
Esophageal Neoplasms
Lung Injury
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Sivelestat
Proteinase Inhibitory Proteins, Secretory
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action