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

NCT ID: NCT03649906

Last Updated: 2021-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2021-06-15

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.

Conditions

Pulmonary Nodule, Solitary

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Optimized Localization Group

Subjects have small pulmonary nodules. In order to facilitate the search for nodules during surgery, it is necessary to indwelling markers pre-operative.

Group Type: EXPERIMENTAL

Optimized Localization Technique

Intervention Type: PROCEDURE

The small pulmonary nodules of the subjects will be located using an optimized pre-loaded microcoil puncture locating method.

Interventions

Optimized Localization Technique

The small pulmonary nodules of the subjects will be located using an optimized pre-loaded microcoil puncture locating method.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Aerospace General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

li fengwei, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Aerospace General Hospital Thoracic surgery department

Locations

Beijing aerospace general hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

Z181100001718055

Identifier Type: -

Identifier Source: org_study_id