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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Patients in the control group received saline for 7 days starting at the beginning of surgery |
|
| S group | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sivelestat sodium hydrate | Drug | saline or sivelestat sodium hydrate intravenously for 7 days starting the beginning of surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary function | the arterial oxygen pressure | 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary function | fraction of inspired oxygen ratio (PF ratio) | 9 days |
| Pulmonary function | the duration of mechanical ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chikara Kunisaki, MD,PhD | Yokohama City University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chikara Kunisaki | Yokohama | Kanagawa | 232-0024 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21557207 | Derived | 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. |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| 9 days |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |