NCT02952261

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 31, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2017

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 1, 2018

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

11 months

First QC Date

October 31, 2016

Results QC Date

February 1, 2018

Last Update Submit

December 1, 2018

Conditions

Lung NeoplasmThoracic Surgery, Video-Assisted

Keywords

Printing, Three-dimensional

Outcome Measures

Primary Outcomes (1)

  • Accuracy of Lung Nodule Localization

    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 Outcomes (3)

  • Procedural Duration of the Nodule Localization

    From the time of completing final CT scan, assessed up to 1 hour.

  • Radiation Dose

    From the time of completing final CT scan, assessed up to 1 hour.

  • Complication Rate

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

Study Arms (2)

CT-guided localization

OTHER

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

Other: CT-guided localization

template-guided localization

EXPERIMENTAL

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

Device: template-guided localization

Interventions

template-guided localizationDEVICE

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.

template-guided localization
CT-guided localizationOTHER

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

CT-guided localization

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (2)

  • 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.

    PMID: 29017792BACKGROUND

  • 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.

    PMID: 30586136DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Dr. Chang Chen
Organization
Shanghai Pulmonary Hospital affiliated to Tongji university
chenthoracic@163.com
+86 13816869003

Study Officials

  • Chang Chen, MD,Ph.D

    Shanghai Pulmonary Hospital, Shanghai, China

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief of thoracic surgery

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 2, 2016

Study Start

October 24, 2016

Primary Completion

October 1, 2017

Study Completion

October 25, 2017

Last Updated

December 19, 2018

Results First Posted

October 1, 2018

Record last verified: 2018-12

Locations

CN(1)