Clinical trial NCT03649906: A Clinical Study of Optimized CT-guided Pulmonary Nodule Microcoil Localization Technique
Official title: A Clinical Study to Evaluate the Efficacy and Safety of A Optimized Computed Tomography-guided Pulmonary Nodule Microcoil Localization Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Nodule, Solitary
Keywords: Micro-coil
CT-guided locate
Lead sponsor: Beijing Aerospace General Hospital
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study intends to use a single set of target values for non-randomized controlled trials, and enrolled 120 subjects who met the inclusion criteria. The small pulmonary nodules were located using an optimized pre-loaded microcoil puncture positioning method. Observe the clinical indicators such as pneumothorax incidence rate, positioning success rate, other complication rate, operation time, and number of operators, and evaluate the safety and effectiveness of the optimized CT-guided pulmonary nodule microcoil localization technique.
Primary purpose: TREATMENT

Brief summary: In the early stage of the study, the CT-guided micro-coil locating method for pulmonary small nodules was optimized. This study will use a single set of target values non-randomized controlled trials to evaluate the safety and effectiveness of the optimized pre-loaded micro-coil locating method in pulmonary small nodules.

Detailed description: A series of optimization and improvement measures were tried for the complications of the CT-guided micro-coil locating method. After discussion, the method of micro-coil pre-loaded in the puncture needle and sealed first, and then for subsequent locating has more advantageous. The method avoids the direct penetration of the puncture needle into the atmosphere during operation, and the operation is simpler. In vitro tests of isolated lung specimens and pre-tests of 9 clinical patients were carried out. The results showed that this method not only reduced the number of operators on site, but also had the tendency to shorten the operation time, reduce the incidence of pneumothorax, and improve the success rate. However, there is currently no rigorous scientific research to provide objective evidence for its safety and effectiveness.

Therefore, this study intends to use a single set of target values non-randomized controlled trials to evaluate the safety and effectiveness of the optimized pre-loaded micro-coil locating method in pulmonary small nodules.

Eligibility criteria: Inclusion Criteria:

1. Patients between 18 years old (including 18 years old) and 85 years old (including 85 years old);
2. The nodule is clinically suspected to be malignant;
3. Those who have no distant metastases;
4. Intrapulmonary lesions must meet the following imaging criteria: ① pure ground glass opacity or non-pure ground glass opacity of solid components ≦ 25%; ②solid nodules with diameter ≦ 1 cm or solid components≦ 1 cm non- purely ground glass, and the distance between the solid component of the nodule and the visceral pleural ≧0.5cm; ③ no pleural traction or involving the pleura.

Exclusion Criteria:

1. The lesion site is not suitable for percutaneous lung puncture;
2. those who have pneumothorax and pleural effusion;
3. Poor general condition, severe damage to cardiopulmonary function, cachexia, and inability to tolerate surgery;
4. Those who refuse surgery;
5. Those who did not sign the informed consent form.

Primary outcomes:
measure: The proportion of patients with pneumothorax.
timeFrame: half an hour after positioning
Secondary outcomes:
measure: Positioning success rate
timeFrame: thoracoscopic surgery
measure: Operation time
timeFrame: At the end of the positioning operation
measure: Number of operators
timeFrame: At the end of the positioning operation
measure: Proportion of patients with complications other than pneumothorax
timeFrame: thoracoscopic surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing aerospace general hospital
state: Beijing
Study officials:
affiliation: Beijing Aerospace General Hospital Thoracic surgery department
name: li fengwei, MD
role: PRINCIPAL_INVESTIGATOR
References: