Lung Cancer
Conditions
Keywords
Electromagnetic navigation bronchoscopy (ENB), localization, Lung cancer, Video-associated thoracic surgery, Indocyanine green (ICG)
Brief summary
The purpose of the study is to evaluate the efficacy and safety of transbronchial ICG and percutaneous hook-wire assisted Video-assisted thoracoscopic sublobar resection. In the control group, CT-guided percutaneous hook-wire preoperative localization will be used for surgical resection; In the experimental group, electromagnetic navigation bronchoscopy guided transbronchial ICG injection will be performed for localization before VATS.
Detailed description
This is a single-center, prospective, randomized trial initiated by the investigator. Subjects with pulmonary nodules who will undergo Video-assisted thoracoscopic sublobar resection will be randomly divided into two groups. In the experimental group, before the VATS operation, transbronchial ICG injection will be guided by electromagnetic navigation bronchoscopy to locate the nodule. In the control group, the subject will undergo CT guided hook-wire placement for nodule localization before VATS. The study is expected to enroll 188 patients. Finally, the effectiveness and safety of the two methods will be compared.
Interventions
DEVICEIndocyanine green (ICG)
Indocyanine green (ICG) was diluted with saline to 0.5mg/mL, and injected 0.6mL/site.
Electromagnetic navigation bronchoscopy (ENB) allows physicians to access peripheral lung nodules with high accuracy and provides a working channel for ICG injection.
DEVICEHook wire
Hook wire is a puncture locating needle with a hook head that is about 1 cm in length and 30 cm metal wire behind. Through the puncture path planned based on CT scan, hook wire puncture percutaneously into the chest cavity to reach the lesion for localization.
Sponsors
Jiayuan Sun
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Above 18 years old; * With lung nodule diameter ≤2cm and distance from pleura ≥1cm, and VATS sublobar resection is arranged; * Located difficultly by intraoperative visual inspection and palpation, a preoperative location is needed.
Exclusion criteria
* Cardiopulmonary function cannot tolerate general anesthesia, or other contraindications, such as uncorrectable coagulopathy; * More than one pulmonary nodule requires preoperative localization; * Subject underwent thoracic surgery in the past and was suspected of having severe chest adhesions; * The nodule puncture path has bony structure block; * Others conditions that the investigator considers not appropriate for this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of the localization procedure | On the 1 day of localization operation | Calculated as follows: (number of successful targeting procedures/number of all localization procedures)\*100 |
| Success rate of the effective localization | On the 1 day of VATS operation | Calculated as follows: \[(number of successful targeting procedures-number of dislodgements or unrecognized in the operative field)/number of all localization procedures\]\*100 |
| Success rate of VATS sublobar resection | On the 1 day of VATS completion | Calculated as follows: (number of successful VATS procedures/number of all localization procedures)\*100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety endpoint | On the 1 day of VATS operation | Complication rate of two localization methods, including pneumothorax, hemorrhage, etc. |
| Localization time | On the 1 day of localization operation | The localization time of the control group was defined as the time from the first CT scan which set the path for percutaneous puncture, to the last CT scan which confirmed the hook wire located at the expected site. The localization time of the experimental group was defined as the time from the insertion of bronchoscope to the glottis, to the withdrawal of bronchoscope from the glottis after ICG injection. |
| Operation time of VATS sublobar resection | On the 1 day of VATS completion | The operation time is defined as the time from the start of the skin incision to the completion of the suture of the skin. |
Countries
China
Contacts
Primary ContactJiayuan Sun, PhD
Outcome results
None listed