Peripheral Pulmonary Nodule
Conditions
Interventions
Intervention Group:ION robotic-assisted navigated bronchoscopy guided lung nodule biopsy
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Able to undergo and physically can withstand a bronchoscopic lung biopsy procedure; 2) Aged 18 to 80 years; 3) Diagnosed with one or more pulmonary nodules by chest CT scan that is suspicious of primary or metastatic malignancy and requires further diagnostic evaluation*; 4) The pulmonary nodules are solid or part-solid; 5) Nodule diameter ranged for 8mm to 30mm in largest dimension; 6) Nodules are peripheral, defined as located at >=4th airway generation (defining trachea as 0 generation, main bronchi as 1st generation, lobar bronchi as the 2nd generation, segmental as 3rd generation, sub-segmental bronchi as the 4th generation); 7) Able to understand and adhere to study requirements; 8) Able to provide and sign informed consent. *For the patients with >1 lesions, only 1 lesion will be biopsied in this study.
Exclusion criteria
Exclusion criteria: 1) Contraindicated for bronchoscopy; 2) Acute myocardial infarction or unstable angina occurred within 6 weeks prior to study procedure; 3) Inability to adequately oxygenate prior to the procedure per physician assessment, or presenting with acute respiratory failure, clinically significant hypoxemia or high respiratory rate prior to procedure; 4) Contraindicated for intubation, general anesthesia or ASA > 3; 5) With known bleeding disorders, history of major bleeding with bronchoscopy; 6) Taking anti-platelet or anti-coagulant medications that cannot be managed appropriately prior to procedure according to standard guidelines (e.g. stopping clopidogrel 7 days prior to procedure, stopping warfarin 5 days prior to procedure, antagonizing with vitamin K, switching to LMWH but keeping INRStage 3 heart failure, uncontrolled pulmonary or systemic hypertension); 12) Known allergy, sensitivity or previous allergic reaction to ortho-phthalaldehyde (OPA); 13) Moderate-to-severe pulmonary fibrosis; 14) Pulmonary nodule associated with lobar atelectasis; 15) Large (>1cm) or Giant bullae within the same lobe of the target pulmonary nodule or within the expected trajectory of biopsy tools during the nodule biopsy; 16) Pleural effusion which may impact the location of lesion on planning or in close proximity to planned biopsy location; 17) Previous segmentectomy within the same lobe of the target nodule . History of total pneumonectomy or lung transplantation; 18) Previous radiation or interventional treatment (e.g. SBRT or ablation) to the same lobe; 19) Pregnancy; 20) Participation in another interventional or investigational clinical trial 30 days prior to the enrollment; 21) Other conditions that Investigator considered not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Users’ acceptance and adoption of the ION Endoluminal System for sampling peripheral nodules.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of device related adverse events;The rate of pneumothorax requiring chest tube placement;The rate of severe bleeding as defined by standard guidelines;Physician assessment of successful navigation to the nodule;Physician assessment of successful biopsy of the target nodule; | — |
Countries
China
Contacts
Public ContactJiayuan Sun
Shanghai Chest Hospital
Outcome results
None listed