JPRN-UMIN000006462
Completed
Phase 2
A Prospective Single-center Observational study on the Efficacy and Safety of the Endo GIA Tri-Staple in patients with Pulmonary Resection - A Prospective Single-center Observational study on the Efficacy and Safety of the Endo GIA Tri-Staple in patients with Pulmonary Resection
Kanagawa Cancer Center Department of Thoracic Surgery0 sites59 target enrollmentOctober 5, 2011
ConditionsBenign or malignant pulmonary lesions
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Benign or malignant pulmonary lesions
- Sponsor
- Kanagawa Cancer Center Department of Thoracic Surgery
- Enrollment
- 59
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\) Patients who are scheduled for a lobectomy and who are found to have a complete interlobar fissure when the chest is opened (surgical stapler is not needed for interlobar separation) 2\) Patients in which factors predicting non\-curable resection for lung cancer, such as pleural dissemination and malignant pleural effusion, are observed when the chest is opened 3\) Patients who are complicated by active infection that requires treatment other than external medicine 4\) Patients who continue on systemic steroid preparation (oral or intravenous) until the day of the operation 5\) Patients who are complicated by poorly controlled diabetes mellitus (HbA1C\>8\.0\) 6\) Functions of the main organs are not maintained (Common terminology criteria for adverse events (CTCAE) ver. 4\.0 Grade\>\=2\). 7\) Patients with malignant pleural effusion or cardiac effusion 8\) Patients who are complicated by psychiatric disorders or psychiatric symptoms and who are judged to have difficulties in participating in the study 9\) Other patients who are considered by the investigator or sub\-investigator as not suitable for participation in this study
Outcomes
Primary Outcomes
Not specified
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