A Clinical Study of Optimized CT-guided Pulmonary Nodule Microcoil Localization Technique

Pulmonary Nodule, Solitary Clinical Trial

Official title:

A Clinical Study to Evaluate the Efficacy and Safety of A Optimized Computed Tomography-guided Pulmonary Nodule Microcoil Localization Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03649906
• Other study ID #: Z181100001718055
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: June 15, 2021

Study information

• Verified date: June 2021
• Source: Beijing Aerospace General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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: ? pure ground glass opacity or non-pure ground glass opacity of solid components ? 25%; ?solid 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; ? 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.

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Nodule, Solitary
• Solitary Pulmonary Nodule

Intervention

Procedure:
• Optimized Localization Technique
The small pulmonary nodules of the subjects will be located using an optimized pre-loaded microcoil puncture locating method.

Locations

Country	Name	City	State
China	Beijing aerospace general hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Aerospace General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with pneumothorax.	Pneumothorax definition: The chest radiograph is examined in the lateral position half an hour after positioning. If a clear pneumothorax line is seen on the chest radiograph, that is, the boundary line between the atrophic lung tissue and the pleural cavity, the pneumothorax is considered to occur.	half an hour after positioning
Secondary	Positioning success rate	The proportion of patients who are successfully positioned. The CT scan was used to determine that the micro-coil was positioned around the nodules in the lungs, and the push and recovery were smooth during the operation. The components did not fall off or tear during the process, which was successful.	thoracoscopic surgery
Secondary	Operation time	The time interval from the first scan to the last scan to confirm that the micro coil is left in place	At the end of the positioning operation
Secondary	Number of operators	Number of people involved in the positioning operation	At the end of the positioning operation
Secondary	Proportion of patients with complications other than pneumothorax		thoracoscopic surgery