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

This study has been completed.
Sponsor:
Information provided by:
Yokohama City University Medical Center
ClinicalTrials.gov Identifier:
NCT01170845
First received: July 23, 2010
Last updated: July 26, 2010
Last verified: March 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Pilot Study of Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Pulmonary function [ Time Frame: 9 days ] [ Designated as safety issue: No ]
    the arterial oxygen pressure


Secondary Outcome Measures:
  • Pulmonary function [ Time Frame: 9 days ] [ Designated as safety issue: No ]
    fraction of inspired oxygen ratio (PF ratio)

  • Pulmonary function [ Time Frame: 9 days ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   55 Years to 77 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Yokohama City University Medical Center

Additional 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
Study First Received: July 23, 2010
Last Updated: July 26, 2010
Health Authority: Japan: Institutional Review Board

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

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Lung Injury
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
ONO 5046
Proteinase Inhibitory Proteins, Secretory
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013