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Completed

NCT Number: NCT02952261

Application of 3D Printing Technique in Small Pulmonary Nodule Localization

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.

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Key information

Conditions

Lung Neoplasm Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Thoracic Surgery, Video-Assisted

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

template-guided localization

Device

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.

CT-guided localization

Other

Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.

Primary outcomes

  1. 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.)

Secondary outcomes

  1. 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.

  2. 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.

  3. Complication Rate

    Time frame: From the time of completing final CT scan, assessed up to 2 days.

    Pnuemothorax related to lung nodule localization

Sponsors and collaborators

Lead sponsor

Chang Chen

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 2, 2016
Registry last updated
Dec 19, 2018

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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