3D Printing for Nodule Localization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-07-01

Brief Summary

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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.

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Detailed Description

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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

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Pulmonary Nodule, Solitary Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

3D-printing guided

Intervention Type PROCEDURE

3D printed navigational template guided

Methylene blue

Intervention Type DRUG

The results are shown by comparison of different colors.

Intraoperative

Intervention Type PROCEDURE

Intraoperative localization.

CT-guided(CT-G)

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

Group Type ACTIVE_COMPARATOR

CT-guided

Intervention Type PROCEDURE

CT-guided

Indocyanine Green

Intervention Type DRUG

The results are shown by comparison of different colors.

Preoperative

Intervention Type PROCEDURE

Preoperative localization.

Interventions

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3D-printing guided

3D printed navigational template guided

Intervention Type PROCEDURE

CT-guided

Intervention Type PROCEDURE

Indocyanine Green

The results are shown by comparison of different colors.

Intervention Type DRUG

Methylene blue

The results are shown by comparison of different colors.

Intervention Type DRUG

Preoperative

Preoperative localization.

Intervention Type PROCEDURE

Intraoperative

Intraoperative localization.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No