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NCT Number: NCT03649906

A Clinical Study of Optimized CT-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.

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Key information

Conditions

Pulmonary Nodule, Solitary Lung Diseases Respiratory Tract Diseases Solitary Pulmonary Nodule

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing aerospace general hospital

Beijing, Beijing Municipality, 100076, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients between 18 years old (including 18 years old) and 85 years old (including 85 years old);
  • The nodule is clinically suspected to be malignant;
  • Those who have no distant metastases;
  • 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

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

Treatment and study plan

Optimized Localization Technique

Procedure

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

Primary outcomes

  1. The proportion of patients with pneumothorax.

    Time frame: half an hour after positioning

    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.

Secondary outcomes

  1. Positioning success rate

    Time frame: thoracoscopic surgery

    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.

  2. Operation time

    Time frame: At the end of the positioning operation

    The time interval from the first scan to the last scan to confirm that the micro coil is left in place

  3. Number of operators

    Time frame: At the end of the positioning operation

    Number of people involved in the positioning operation

  4. Proportion of patients with complications other than pneumothorax

    Time frame: thoracoscopic surgery

Sponsors and collaborators

Lead sponsor

Beijing Aerospace General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 28, 2018
Registry last updated
Jun 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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