Pulmonary Nodule Localization Prospective Validation

• Conditions: Pulmonary Nodules; Video-assisted Thoracic Surgery

• Registration Number: NCT04690790
• Lead Sponsor: E-DA Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2020-12-28
• Study First Submitted QC: 2020-12-28
• Study First Posted: 2020-12-31
• Status Verified: 2021-01
• Study Start: 2021-01-23
• Last Update Submitted: 2021-01-23
• Last Update Posted: 2021-01-26
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nodule detection	During surgery	Whether the nodule could be detected by conventional visualization or palpation

Trial Locations

Locations (1)

E-DA Hospital; 🇨🇳 Kaohsiung, Taiwan