Clinical trial · Interventional
Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy
A Pilot Study of Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy
NCT01170845CI-TRIAL-00003712NEIEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sivelestat sodium hydrate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- Patients in the control group received saline for 7 days starting at the beginning of surgery
- interventionNames
- Drug: sivelestat sodium hydrate
- type
- ACTIVE_COMPARATOR
- label
- S group
- 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
- interventionNames
- Drug: sivelestat sodium hydrate
Primary outcomes (1)
- measure
- Pulmonary function
- timeFrame
- 9 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 77 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMakino 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. PMID 21557207