Clinical Trials Directory

Trials / Completed

CompletedNCT04056923

3D Printing for Nodule Localization

Three-dimensionally Printed Navigational Template for Localizing Small Pulmonary Nodules

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
47 (actual)
Sponsor
Wen-zhao ZHONG · Unknown
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Implementation of lung cancer screening using low-dose computed tomography has increased the rate of detection of small peripheral pulmonary nodules. However, it is hard to localize these nodules by palpation because of their small volume and long distance to the nearest pleural surface. To further clarify the confounding factors, we developed our own 3D printing localization procedure. In contrast to traditional CT-G percutaneous puncture localization, our procedure was performed in the operating room without CT scan evaluation.

Detailed description

Pulmonary wedge resection is one of the most common types of operations performed by thoracic surgeons, especially given that more and more patients with ground glass nodules are being detected recently. One of the most significant current discussion concerning wedge resection is nodule localization. At present, a commonly used localization method is the CT-guided percutaneous lung puncture methylene blue staining marker localization, but this method has two main disadvantages: 1. the methylene blue dye is easy to spread, affecting the intraoperative judgment of nodule position by surgeon; 2. patients often suffer additional CT radiation. In recent years, the three-dimensional (3D) printing technique has been gradually applied to clinical therapy. However, 3D-printed template-guided (3D-G) localization required pre-evaluation by CT scanning. If deviation of more than 2 cm was found on the CT scan, the 3D-G method was regarded as a failure and traditional CT-G hookwire localization was used. To further clarify the confounding factors, the investigators developed their own 3D printing localization procedure. In contrast to traditional CT-G percutaneous puncture localization, the 3D printing localization procedure was performed in the operating room without CT scan evaluation.

Conditions

Interventions

TypeNameDescription
PROCEDURE3D-printing guided3D printed navigational template guided
PROCEDURECT-guidedCT-guided
DRUGIndocyanine GreenThe results are shown by comparison of different colors.
DRUGMethylene blueThe results are shown by comparison of different colors.
PROCEDUREPreoperativePreoperative localization.
PROCEDUREIntraoperativeIntraoperative localization.

Timeline

Start date
2018-01-01
Primary completion
2018-06-07
Completion
2018-07-01
First posted
2019-08-14
Last updated
2019-08-14

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT04056923. Inclusion in this directory is not an endorsement.