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
-
-
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
|
saline or sivelestat sodium hydrate intravenously for 7 days starting the beginning of surgery
Other Names:
|
|
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
|
saline or sivelestat sodium hydrate intravenously for 7 days starting the beginning of surgery
Other Names:
|
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.
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.
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
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.