Benign or malignant pulmonary lesions
Conditions
Interventions
Sponsors
Kanagawa Cancer Center Department of Thoracic Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pulmonary resection (excluding pneumonectomy) using surgical stapler is scheduled (regardless of cancer or non-cancer). 2) 20 years old or older (no upper limit) 3) No past history of ipsilateral thoracotomy 4) No past history of radiation therapy in the chest 5) No past history of chemotherapy with anticancer agent/s 6) Eastern Cooperative Oncology Group Scale of Performance Status (ECOG PS) of either 0 or 1 7) Written informed consent is obtained from the patient him/herself.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of prolomged air leaks (pulmonary fistula) that continue for more than five postoperative days | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of air leaks occurring in the cut end during operation, incidence and degree of damage to the pleura, staple formation, haemostatic effect on the staple line, presence or absence of additional suture, whether or not sealing technique is applied and applied procedure, incidence of perioperative and postoperative adverse events, duration of placement of drain, duration of hospitalization (days) | — |
Countries
Japan
Contacts
Public ContactMasahiro Tsuboi
Kanagawa Cancer Center Department of Thoracic Surgery
Outcome results
None listed