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

July 26, 2010 updated by: Yokohama City University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 232-0024
        • Chikara Kunisaki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary function
Time Frame: 9 days
the arterial oxygen pressure
9 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary function
Time Frame: 9 days
fraction of inspired oxygen ratio (PF ratio)
9 days
Pulmonary function
Time Frame: 9 days
the duration of mechanical ventilation
9 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yokohama City University Medical Center

Investigators

  • Study Chair: Chikara Kunisaki, MD,PhD, Yokohama City University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

July 23, 2010

First Submitted That Met QC Criteria

July 26, 2010

First Posted (Estimate)

July 27, 2010

Study Record Updates

Last Update Posted (Estimate)

July 27, 2010

Last Update Submitted That Met QC Criteria

July 26, 2010

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 531

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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