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Application of 3D Printing Technique in Small Pulmonary Nodule Localization

NCT ID: NCT02952261

Last Updated: 2018-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-24

Study Completion Date

2017-10-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Neoplasm Thoracic Surgery, Video-Assisted

Keywords

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Printing, Three-dimensional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CT-guided localization

This group of participants received conventional CT-guided lung nodule localization.

Group Type OTHER

CT-guided localization

Intervention Type 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.

template-guided localization

Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.

Group Type EXPERIMENTAL

template-guided localization

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Chen

OTHER

Sponsor Role lead

Responsible Party

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Chang Chen

Chief of thoracic surgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Chang Chen, MD,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital, Shanghai, China

Locations

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Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Zhang L, Li M, Li Z, Kedeer X, Wang L, Fan Z, Chen C. Three-dimensional printing of navigational template in localization of pulmonary nodule: A pilot study. J Thorac Cardiovasc Surg. 2017 Dec;154(6):2113-2119.e7. doi: 10.1016/j.jtcvs.2017.08.065. Epub 2017 Sep 1.

Reference Type BACKGROUND
PMID: 29017792 (View on PubMed)

Zhang L, Wang L, Kadeer X, Zeyao L, Sun X, Sun W, She Y, Xie D, Li M, Zou L, Rocco G, Yang P, Chen C, Liu CC, Petersen RH, Ng CSH, Parrish S, Zhang YS, Giordano R, di Tommaso L; AME Thoracic Surgery Collaborative Group. Accuracy of a 3-Dimensionally Printed Navigational Template for Localizing Small Pulmonary Nodules: A Noninferiority Randomized Clinical Trial. JAMA Surg. 2019 Apr 1;154(4):295-303. doi: 10.1001/jamasurg.2018.4872.

Reference Type DERIVED
PMID: 30586136 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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k16-284

Identifier Type: -

Identifier Source: org_study_id