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

B

Beijing Aerospace General Hospital

Status

Completed

Conditions

Pulmonary Nodule, Solitary

Treatments

Procedure: Optimized Localization Technique

Study type

Interventional

Funder types

Other

Identifiers

NCT03649906
Z181100001718055

Details and patient eligibility

About

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.

Full 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.

Enrollment

125 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

125 participants in 1 patient group

Optimized Localization Group
Experimental group
Description:
Subjects have small pulmonary nodules. In order to facilitate the search for nodules during surgery, it is necessary to indwelling markers pre-operative.
Treatment:
Procedure: Optimized Localization Technique

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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