3D Printing for Nodule Localization

Sponsor

Wen-zhao ZHONG (Other)

Overall Status

Completed

CT.gov ID

NCT04056923

Collaborator

Zhuhai Seine Technology Co., Ltd, Zhuhai city, China (Other)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Nodule, Solitary Lung Cancer	Procedure: 3D-printing guided Procedure: CT-guided Drug: Indocyanine Green Drug: Methylene blue Procedure: Preoperative Procedure: Intraoperative	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Three-dimensionally Printed Navigational Template for Localizing Small Pulmonary Nodules

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Jun 7, 2018

Actual Study Completion Date :

Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3D-printed template-guided(3D-G) Intraoperative 3D-G methylene blue dye marking in the operating room	Procedure: 3D-printing guided 3D printed navigational template guided Drug: Methylene blue The results are shown by comparison of different colors. Procedure: Intraoperative Intraoperative localization.
Active Comparator: CT-guided(CT-G) Preoperative localization is performed by CT-G indocyanine green marking in the radiology department	Procedure: CT-guided CT-guided Drug: Indocyanine Green The results are shown by comparison of different colors. Procedure: Preoperative Preoperative localization.

Arm

Intervention/Treatment

Experimental: 3D-printed template-guided(3D-G)

Intraoperative 3D-G methylene blue dye marking in the operating room

Procedure: 3D-printing guided

3D printed navigational template guided

Drug: Methylene blue

The results are shown by comparison of different colors.

Procedure: Intraoperative

Intraoperative localization.

Active Comparator: CT-guided(CT-G)

Preoperative localization is performed by CT-G indocyanine green marking in the radiology department

Procedure: CT-guided

CT-guided

Drug: Indocyanine Green

The results are shown by comparison of different colors.

Procedure: Preoperative

Preoperative localization.

Outcome Measures

Primary Outcome Measures

Localization distance [Day of surgery]
The distance of the two stain points from the tumor. The investigators use a sterile, standard ruler to measure the distance. Based on our previous experience with CT-G localization, a deviation of less than 2 cm was considered a successful localization.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

a maximum target lung nodule diameter ≤20 mm;
a target nodule consolidation/tumor ratio (CTR) <0.25, or a minimum distance from the outer edge of the nodule to the nearest pleural surface >10 mm if the target nodule CTR was >0.25.

Exclusion Criteria:

Inability to comply with research protocols or research procedures
Any unstable systemic disease (including active infections, uncontrolled high blood pressure, unstable angina, angina pectoris that has started within the last 3 months, congestive heart failure (≥ New York Heart Association [NYHA] Level II ), cardiac infarction (6 months before enrollment), severe arrhythmia requiring medication, liver, kidney or metabolic disease
Active bleeding; Inability to withstand lying flat; Inability to cooperate through breathing during puncture
Pregnant or lactating women
Other circumstances that the investigator believes are not suitable for enrollment