Esophageal Cancer
Conditions
Keywords
Esophagectomy, Postoperative respiratory complications, neutrophil elastase inhibitor
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.
Interventions
saline or sivelestat sodium hydrate intravenously for 7 days starting the beginning of surgery
Sponsors
Yokohama City University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
55 Years to 77 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary function | 9 days | the arterial oxygen pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary function | 9 days | fraction of inspired oxygen ratio (PF ratio) |
Countries
Japan
Outcome results
None listed