Pulmonary Nodule Localization Prospective Validation

Video-assisted Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04690790
• Other study ID #: EMRP56109N
• Status: Recruiting
• Start date: January 23, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2021
• Source: E-DA Hospital
• Contact: Ming-Wei Kao, M.D., M.S.
• Phone: +886-7-6150011
• Email: ed107576[@]edah.org.tw
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Nodules
• Video-assisted Thoracic Surgery

Intervention

Procedure:
• Thoracoscopy
Patients who are indicated for thoracoscopic nodulectomy.

Locations

Country	Name	City	State
Taiwan	E-DA Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
E-DA Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nodule detection	Whether the nodule could be detected by conventional visualization or palpation	During surgery