3D Printing for Nodule Localization
August 13, 2019 updated by: Wen-zhao ZHONG
Three-dimensionally Printed Navigational Template for Localizing Small Pulmonary Nodules
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
47
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China
- Guangdong Provincial People's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 3D-printed template-guided(3D-G)
Intraoperative 3D-G methylene blue dye marking in the operating room
|
3D printed navigational template guided
The results are shown by comparison of different colors.
Intraoperative localization.
|
|
ACTIVE_COMPARATOR: CT-guided(CT-G)
Preoperative localization is performed by CT-G indocyanine green marking in the radiology department
|
CT-guided
The results are shown by comparison of different colors.
Preoperative localization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Day of surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2018
Primary Completion (ACTUAL)
June 7, 2018
Study Completion (ACTUAL)
July 1, 2018
Study Registration Dates
First Submitted
August 12, 2019
First Submitted That Met QC Criteria
August 13, 2019
First Posted (ACTUAL)
August 14, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 14, 2019
Last Update Submitted That Met QC Criteria
August 13, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3D printing navigation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.