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

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
sivelestat sodium hydrate
Sponsored by
Yokohama City University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophagectomy, Postoperative respiratory complications, neutrophil elastase inhibitor

Eligibility Criteria

55 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chikara Kunisaki

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control group

S group

Arm Description

Patients in the control group received saline for 7 days starting at the beginning of surgery

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

Outcomes

Primary Outcome Measures

Pulmonary function
the arterial oxygen pressure

Secondary Outcome Measures

Pulmonary function
fraction of inspired oxygen ratio (PF ratio)
Pulmonary function
the duration of mechanical ventilation

Full Information

First Posted
July 23, 2010
Last Updated
July 26, 2010
Sponsor
Yokohama City University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01170845
Brief Title
Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy
Acronym
NEIE
Official Title
A Pilot Study of Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Yokohama City University Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Esophagectomy, Postoperative respiratory complications, neutrophil elastase inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients in the control group received saline for 7 days starting at the beginning of surgery
Arm Title
S group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
sivelestat sodium hydrate
Other Intervention Name(s)
Elaspol
Intervention Description
saline or sivelestat sodium hydrate intravenously for 7 days starting the beginning of surgery
Primary Outcome Measure Information:
Title
Pulmonary function
Description
the arterial oxygen pressure
Time Frame
9 days
Secondary Outcome Measure Information:
Title
Pulmonary function
Description
fraction of inspired oxygen ratio (PF ratio)
Time Frame
9 days
Title
Pulmonary function
Description
the duration of mechanical ventilation
Time Frame
9 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chikara Kunisaki, MD,PhD
Organizational Affiliation
Yokohama City University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Chikara Kunisaki
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
21557207
Citation
Makino H, Kunisaki C, Kosaka T, Akiyama H, Morita S, Endo I. Perioperative use of a neutrophil elastase inhibitor in video-assisted thoracoscopic oesophagectomy for cancer. Br J Surg. 2011 Jul;98(7):975-82. doi: 10.1002/bjs.7499. Epub 2011 May 9.
Results Reference
derived

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Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy

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