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

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ClinicalTrials.gov Identifier: NCT01170845
Recruitment Status : Completed
First Posted : July 27, 2010
Last Update Posted : July 27, 2010
Sponsor:
Information provided by:
Yokohama City University Medical Center

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
Esophageal Cancer Drug: sivelestat sodium hydrate Not Applicable

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  (Clinical Trial)
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 : March 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


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 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




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


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

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



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Ages Eligible for Study:   55 Years to 77 Years   (Adult, Older Adult)
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

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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

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 Posted: July 27, 2010    Key Record Dates
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