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Clinical Trials/JPRN-UMIN000006462
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

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.

Registry
who.int
Start Date
October 5, 2011
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Kanagawa Cancer Center Department of Thoracic Surgery

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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