Application of 3D Printing Technique in Small Pulmonary Nodule Localization

December 1, 2018 updated by: Chang Chen

Three-Dimensional Printing of Navigational Template in Localization of Small Pulmonary Nodule: A Prospective, Randomized, Controlled, Non-inferiority Trial

The trial is to evaluate the efficacy and safety of three-dimensional printed navigational template in the clinical application of small peripheral lung nodule localization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Localization of small lung nodule is challenging due to the difficulty of nodule recognition during VATS. A three-dimensional printed navigational template was designed to aid percutaneous lung nodule localization, and its feasibility has been confirmed in previous study. The trial was conducted to confirm the non-inferiority of template-guided method to conventional CT-guided method in terms of localization accuracy.

Study Type

Interventional

Enrollment (Actual)

200

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

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Shanghai Pulmonary 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

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged from 19 to 80 years
  2. lesions located in peripheral lung tissue which can be removed by wedge resection
  3. The maximum diameter of the lesion is no more than 20 mm.
  4. Research assistant consulted with the patient's surgeon to confirm the necessity of lung nodule localization
  5. Informed consent was signed voluntarily.

Exclusion Criteria:

  1. nodule located in the scapula region.
  2. there were two or more lung nodules needed to be localized.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CT-guided localization
This group of participants received conventional CT-guided lung nodule localization.
Other: CT-guided localization
Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.
Experimental: template-guided localization
Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.
Device: template-guided localization
Based on CT data, digital model of the navigational template was created using CAD software and imported to 3D printer. The navigational template serves as a guider to the localizer in lung nodule localization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of Lung Nodule Localization
Time Frame: From the time of completing final CT scan, assessed up to 2 days.
Localization accuracy was defined by the localizer deviation between the hookwire and the center of the target nodule. (The deviation was measured using CAD software after downloading the CT images from the Picture Archiving and Communication Systems.)
From the time of completing final CT scan, assessed up to 2 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural Duration of the Nodule Localization
Time Frame: From the time of completing final CT scan, assessed up to 1 hour.
Procedural duration was derived from CT scan parameters, which was calculated as the time length between the initial and final scan.
From the time of completing final CT scan, assessed up to 1 hour.
Radiation Dose
Time Frame: From the time of completing final CT scan, assessed up to 1 hour.
Radiation dosage was read on the monitor screen of CT scanner and converted to effective dosage.
From the time of completing final CT scan, assessed up to 1 hour.
Complication Rate
Time Frame: From the time of completing final CT scan, assessed up to 2 days.
Pnuemothorax related to lung nodule localization
From the time of completing final CT scan, assessed up to 2 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Chen

Investigators

  • Principal Investigator: Chang Chen, MD,Ph.D, Shanghai Pulmonary Hospital, Shanghai, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 24, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 25, 2017

Study Registration Dates

First Submitted

October 31, 2016

First Submitted That Met QC Criteria

November 1, 2016

First Posted (Estimate)

November 2, 2016

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 1, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • k16-284

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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