A pulmonary lesion suspected or diagnosed as malignancy
Conditions
Interventions
Bronchoscopic lung marking (Only once) Surgery (conducted within 2 days after bronchoscopic lung marking)
Sponsors
Ministry of health, labor, and welfare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A pulmonary lesion or lesions suspected of or diagnosed with malignancy, the resection of which needs determination of resection lines other than standard lobectomy 2) A pulomnary lesion or lesions that is anticipated to be hardly identifiable during surgery and necessitate careful determination of resection lines to obtain sufficient resection margins, including: A) A lesion or lesions anticipated to be hardly identifiable during surgery due to the lesion's characteristics such as i) A component of ground glass opacity as a part or a whole of the lesion ii) A lesion the diameter of which is smaller than or equal to 5 mm iii) A lesion the distance from the closest visceral pleura is larger than the lesion's diameter B) A pulmonary lesion or lesions anticipated to be hardly identifiable during surgery because of the condition of the underlying lung such as i) Anticipated tight pleural adhesion (e.g, previous open chest surgery) ii) Existence of confusing benign nodules (e.g., silicosis, old tuberculosis) C) Other lesions or conditions fo which surgeons consider markings are particularly necessary 3) Consent obtained from the patient or a representative 4) At least two certified thoracic surgeons agree with the necessity of markings at the time of registration
Exclusion criteria
Exclusion criteria: 1) Allergic to indigocarmine 2) Pregnant 3) Complications that do not allow for bronchoscopy or the marking procedure 4) Other cases a medical doctor in charge judged as inappropriate for registeration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful resection of pulmonary lesions with sufficient resection margins* *Resection margins larger than the tumor diameter or 2 cm | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Efficacy of markings 2) Efficacy of marking-assisted surgery 3) Safety (observed until post-operative day 30) | — |
Countries
Japan
Contacts
Public ContactMasaaki Sato
The University of Tokyo Hospital Thoracic Surgery
Outcome results
None listed