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NEIE: Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy

Sponsor
Yokohama City University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01170845
Collaborator
(none)
31
Enrollment
1
Location
2
Arms
24
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: sivelestat sodium hydrate
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
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
Study Start Date :
Mar 1, 2007
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Mar 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Elaspol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pulmonary function [9 days]

      the arterial oxygen pressure

    Secondary Outcome Measures

    1. Pulmonary function [9 days]

      fraction of inspired oxygen ratio (PF ratio)

    2. Pulmonary function [9 days]

      the duration of mechanical ventilation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 77 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01170845
    Other Study ID Numbers:
    • 531
    First Posted:
    Jul 27, 2010
    Last Update Posted:
    Jul 27, 2010
    Last Verified:
    Mar 1, 2007
    Keywords provided by , ,
    Esophagectomy
    Postoperative respiratory complications
    neutrophil elastase inhibitor
    Additional relevant MeSH terms:
    Lung Injury
    Sivelestat

    Study Results

    No Results Posted as of Jul 27, 2010