3D Printing for Nodule Localization

Not Applicable

Completed

• Conditions: Pulmonary Nodule, Solitary; Lung Cancer
• Interventions: Procedure: 3D-printing guided; Procedure: CT-guided; Drug: Methylene blue; Drug: Indocyanine Green; Procedure: Intraoperative; Procedure: Preoperative

• Registration Number: NCT04056923
• Lead Sponsor: Wen-zhao ZHONG

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.

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 Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-06-07
• Study Completion: 2018-07-01
• Status Verified: 2019-08
• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-13
• Last Update Submitted: 2019-08-13
• Study First Posted: 2019-08-14
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D-printed template-guided(3D-G)	3D-printing guided	Intraoperative 3D-G methylene blue dye marking in the operating room
3D-printed template-guided(3D-G)	Methylene blue	Intraoperative 3D-G methylene blue dye marking in the operating room
3D-printed template-guided(3D-G)	Intraoperative	Intraoperative 3D-G methylene blue dye marking in the operating room
CT-guided(CT-G)	CT-guided	Preoperative localization is performed by CT-G indocyanine green marking in the radiology department
CT-guided(CT-G)	Indocyanine Green	Preoperative localization is performed by CT-G indocyanine green marking in the radiology department
CT-guided(CT-G)	Preoperative	Preoperative localization is performed by CT-G indocyanine green marking in the radiology department

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China