Localization for Deep Lung Nodules: Microcoil Versus Contrast Injection
- Registration Number
- NCT03617029
- Lead Sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Brief Summary
In recent years, the development of low-dose pulmonary computed tomography screening has led to the discovery of many small pulmonary nodules in the early stages.
Surgical resection is still the main treatment for those suspected malignant lesions. In the face of such small pulmonary nodules, accurate preoperative localization has become the key to successful resection, and the deep-seated nodules are the most challenging parts. Because the deep-seated nodules cannot be localized by surface dye injection, however, it is necessary to place a fiducial marker (such as a microcoil) or contrast medium injection in combination with intraoperative fluoroscopy to ensure adequate resection of the deep-seated nodules. . This study will be carried out at the Hsinchu Branch of National Taiwan University Hospital. It is expected that 60 patients with pulmonary nodules with a depth larger than 2 cm will be randomly assigned into two groups. One group will receive microcoil placement, and the other group will receive contrast medium injection. The primary goal of the study was to compare the localization duration of the two groups of patients, the total dose of radiation exposure during localization and the incidence of location-related complications, and the secondary goals were the results of the surgical procedure, including the surgical duration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Deep lung lesions
Emphysema COPD Previous ilpislateral surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Microcoil Microcoil Needle localization for deep-seated lung nodules with microcoil placement Contrast Lipiodol Needle localization for deep-seated lung nodules with contrast injection
- Primary Outcome Measures
Name Time Method Successful localization for surgery 1 day Localization contribute to surgery
Procedure success rate 1 day Procedure success is defined as marking (lipiodol or hook-wire) the GGO lesion within 1 cm without pleural leakage of lipiodol or dislodgement of the hook-wire. The procedure success rate is calculated as follows: procedure success rate (%) = (number of procedure success / number of total procedure) × 100.
- Secondary Outcome Measures
Name Time Method Procedure-related complication rate 1 day Incidence of complications during needle procedure, The procedure-related complication rate is calculated as follows: procedure-related complication rate (%) = (number of procedure-related complication / number of total procedure) × 100.
Duration of the localization procedure 1 day From start of needle procedure to withdraw of the needle (minutes)
Duration of wedge resection 1 day From start of surgery to completion of pulmonary wedge resection (minutes)
Surgical margin of wedge resection 1 day Distance from pulmonary lesion to resection margin of the specimen
Trial Locations
- Locations (1)
National Taiwan University Hospital, Hsin-Chu Branch
🇨🇳Taipei, Hsin-Chu County, Taiwan