Comparing of Microcoil Localization and Hook Wire Localization for Resectable Pulmonary Small Nodules

Study Overview
=================
Brief Summary
-----------------
Both of microcoil localization and hookwire localization have been proved as good preoperative CT(computed tomography)-guided techniques to guide VATS resection for the diagnosis of small peripheral pulmonary nodules technique to guide VATS resection for the diagnosis of small peripheral pulmonary nodules. The objective of this study is to determine if microcoil localization for pulmonary nodules can be safer than hookwire localization

Detailed Description
-----------------
Both of microcoil localization and hookwire localization have been proved as good preoperative CT-guided techniques to guide VATS resection for the diagnosis of small peripheral pulmonary nodules technique to guide VATS(video assisted thoracoscopic surgery) resection for the diagnosis of small peripheral pulmonary nodules. Compared with the commonly used hook wire, the platinum microcoil can be retained in the patients'body and the configuration of which had an effect in reducing the severity of complications. The fibered microcoil may promote blood coagulation of the surrounding lung tissues, block the needle pathway, and decrease the severity of pneumothorax and bleeding caused by the puncture needle, which has been proven in animal experiments. The objective of this study is to determine if microcoil localization for pulmonary nodules can be safer than hookwire localization

Official Title
-----------------
Comparing of Computed Tomography Guided Microcoil Localization and Hook Wire Localization for Pulmonary Small Nodules and Ground-glass Opacity Prior to Thoracoscopic Resection

Conditions
-----------------
Thoracic Surgery

Intervention / Treatment
-----------------
* Procedure: microcoil localization
* Procedure: hookwire localization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: solid nodules with a diameter ≤1 cm and distance to visceral pleura ≥0.5 cm, -ground-glass nodules, part-solid ground-glass nodules, with a solid portion ≤1 cm and distance to the visceral pleura ≥1 cm. peripheral nodules amenable to thoracoscopic wedge excision of the nodules. Exclusion Criteria: Patients combined with pneumothorax. Patients combined with pleural effusion. Patients with history of hemoptysis. Patients with medical condition that the radiologist and surgeon disagree for inclusion.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: microcoil<br>patients who plan for microcoil localization | Procedure: microcoil localization<br>* CT-guided localization by placing a microcoil into the lung parenchyma<br>|
| Placebo Comparator: hookwire<br>patients who plan for hookwire localization | Procedure: hookwire localization<br>* CT-guided localization by placing a hookwire into the lung parenchyma<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications after CT-guided localization | any complication occured after CT-guided localization | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major complications after CT-guided localization | major complication refers to complication that need to be interfered before surgery | 1 years | 
| success of the intervention of localization | success of the intervention of CT guided localization by microcoil or hookwire | 1 year | 
| success of the localization by thoracoscopic surgery | success of the localization by thoracoscopic surgery under the guide of the planted microcoil or hookwire | 1 year |