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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Nodule, Solitary
• Intervention / Treatment: Procedure: Optimized Localization Technique

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.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100076
      • Beijing aerospace general hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Optimized Localization Technique; The small pulmonary nodules of the subjects will be located using an optimized pre-loaded microcoil puncture locating method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Number of operators	Number of people involved in the positioning operation	At the end of the positioning operation
Proportion of patients with complications other than pneumothorax		thoracoscopic surgery

Collaborators and Investigators

• Sponsor: Beijing Aerospace General Hospital
• Investigators: Principal Investigator: li fengwei, MD, Beijing Aerospace General Hospital Thoracic surgery department

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): June 15, 2021
• Study Completion (Actual): June 15, 2021

Study Registration Dates

• First Submitted: August 26, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Micro-coil; CT-guided locate
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules; Solitary Pulmonary Nodule
• Other Study ID Numbers: Z181100001718055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Our hospital medical ethics committee does not allow us to share patients personal data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No