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Completed

NCT Number: NCT04056923

3D Printing for Nodule Localization

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

3D-printing guided

Procedure

3D printed navigational template guided

CT-guided

Procedure

CT-guided

Indocyanine green

Drug

The results are shown by comparison of different colors.

Methylene Blue

Drug

The results are shown by comparison of different colors.

Preoperative

Procedure

Preoperative localization.

Intraoperative

Procedure

Intraoperative localization.

Primary outcomes

  1. Localization distance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wen-zhao ZHONG

Other

Collaborators

  • Zhuhai Seine Technology Co., Ltd, Zhuhai city, China

Registry information

Official study title

Three-dimensionally Printed Navigational Template for Localizing Small Pulmonary Nodules

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2019
Registry last updated
Aug 14, 2019

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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