lung malignant tumor
Conditions
Interventions
On the day prior to surgery or on the day of surgery, under CT fluoroscopy guidance and local anesthesia with 1% lidocaine, a 21- or 23-gauge needle is used to puncture the pulmonary lesion or the sur
Sponsors
Matsui Takuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The patient clinically suspected of lung malignancies with radiologically confirmed resectable lesions in the lungs. 2) The patient is scheduled to undergo a thoracoscopic limited resection (either wedge resection or segmentectomy) for the malignant lung tumor. 3) The patient has no history of iodine allergy. 4) Patients who are 18 years or older at the time of signing the consent form. 5) Patients with an ECOG Performance Status (ECOG PS) of 0 to 2 at the time of registration. 6) Patients who are capable of complying with the study protocol requirements. 7) Patients who have understood the contents of the informed consent form and provided written consent of their own free will.
Exclusion criteria
Exclusion criteria: 1) Patients with a history of asthma. 2) Patients with severe comorbidities (such as uncontrolled hypertension or diabetes). 3) Patients with serious infections, including active tuberculosis. 4) Patients with a predisposition to allergies. 5) Pregnant women, breastfeeding women, or women who might be pregnant. 6) Patients who are unwilling to use contraception. 7) Patients for whom participation in the trial is difficult due to psychiatric disorders or mental symptoms. 8) Other patients deemed unsuitable by the principal investigator (or sub-investigators).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [Efficacy] Success rate of localization [Safety] The following adverse events and side effects caused by the investigational drug 1) Drug allergies and related events 2) Occurrence of adverse events related to the investigational drug 3) Occurrence of serious adverse events related to the investigational drug | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Distance between resection edge and tumor margin 2) Local recurrence-free survival rate (for primary lung cancer cases only) 3) Overall recurrence-free survival rate (for primary lung cancer cases only) 4) Overall survival rate (for primary lung cancer cases only) 5) Complication rate related to marking 6) Operative time 7) Blood loss 8) Intraoperative complication rate 9) Postoperative hospital stay 10) Postoperative complication rate 11) Postoperative pulmonary function | — |
Contacts
Public ContactMana Ichie
Aichi Cancer Center Hospital
Outcome results
None listed