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临床试验/NCT04056923
NCT04056923已完成不适用

Three-dimensionally Printed Navigational Template for Localizing Small Pulmonary Nodules

Wen-zhao ZHONG1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2018年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
47
试验地点
1
主要终点
Localization distance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

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

Experimental

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

干预措施: 3D-printing guided (Procedure)

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

Experimental

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

干预措施: Methylene blue (Drug)

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

Experimental

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

干预措施: Intraoperative (Procedure)

CT-guided(CT-G)

Active Comparator

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

干预措施: CT-guided (Procedure)

CT-guided(CT-G)

Active Comparator

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

干预措施: Indocyanine Green (Drug)

CT-guided(CT-G)

Active Comparator

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

干预措施: Preoperative (Procedure)

结局指标

主要结局

Localization distance

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Wen-zhao ZHONG
申办方类型
Unknown
责任方
Sponsor Investigator
主要研究者

Wen-zhao ZHONG

M.D., Ph.D., Chief physician

Guangdong Provincial People's Hospital

研究点 (1)

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