Pulmonary Nodule Localization Prospective Validation

January 23, 2021 updated by: Tu, Yuan-Kun, E-DA Hospital

Pulmonary Nodule Localization Under Thoracoscopic Surgery- a Machine Learning Based Retrospective Analysis and Prospective Validation

Localization is the key for successful excision of small target nodules under thoracoscopy, but the procedure also brings risks to patients. However, the criteria is still unclear. The investigators will validate the prediction model produced by institutional retrospective analysis in the prospective cohort.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Excision of targeted lung nodules during thoracoscopy sometimes needs placing a mark before surgery. The procedure of mark placement (localization) could probably cause damages to the patients. However, the criteria for patient selection is still not clear. Through respective analysis, the investigators have set up a prediction model and wish to validate this model prospectively.

Study Type

Observational

Enrollment (Anticipated)

50

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

  • Taiwan
      • Kaohsiung, Taiwan, 824
        • Recruiting
        • E-DA Hospital
        • Contact:
        • Principal Investigator:
          • Ming-Wei Kao

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

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients indicated for thoracoscopic nodulectomy

Description

Inclusion Criteria:

  • Age ≧ 20 years
  • Lung nodule size ≦2cm on the pre-operative computed tomography (CT)
  • Nodulectomy is performed under thoracoscopy

Exclusion Criteria:

  • Age < 20 years
  • Lung nodule size > 2cm on CT or in the final pathology report
  • Open surgery for nodulectomy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nodule detection
Time Frame: During surgery
Whether the nodule could be detected by conventional visualization or palpation
During surgery

Collaborators and Investigators

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

Sponsor

E-DA Hospital

Investigators

  • Principal Investigator: Ming-Wei Kao, M.D., M.S., E-DA Hospital

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 23, 2021

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

December 28, 2020

First Submitted That Met QC Criteria

December 28, 2020

First Posted (ACTUAL)

December 31, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 23, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMRP56109N

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.

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