Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy
- Registration Number
- NCT01170845
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group sivelestat sodium hydrate Patients in the control group received saline for 7 days starting at the beginning of surgery S group sivelestat sodium hydrate 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
- Primary Outcome Measures
Name Time Method Pulmonary function 9 days the arterial oxygen pressure
- Secondary Outcome Measures
Name Time Method Pulmonary function 9 days the duration of mechanical ventilation
Trial Locations
- Locations (1)
Chikara Kunisaki
🇯🇵Yokohama, Kanagawa, Japan