Pulmonary Nodule Localization Prospective Validation

• Sponsor: E-DA Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04690790
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 11.2
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Video-assisted Thoracic Surgery; Pulmonary Nodules	Procedure: Thoracoscopy

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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Pulmonary Nodule Localization Under Thoracoscopic Surgery- a Machine Learning Based Retrospective Analysis and Prospective Validation
• Actual Study Start Date: Jan 23, 2021
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Outcome Measures

Primary Outcome Measures

1. Nodule detection [During surgery]

   Whether the nodule could be detected by conventional visualization or palpation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	E-DA Hospital	Kaohsiung		Taiwan	824

Sponsors and Collaborators

• E-DA Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tu, Yuan-Kun, president, E-DA Hospital
• ClinicalTrials.gov Identifier: NCT04690790
• Other Study ID Numbers: EMRP56109N
• First Posted: Dec 31, 2020
• Last Update Posted: Jan 26, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tu, Yuan-Kun, president, E-DA Hospital: Video-assisted thoracic surgery; Thoracoscopy; Localization; Pulmonary nodules
• Additional relevant MeSH terms: Multiple Pulmonary Nodules

Study Results

No Results Posted as of Jan 26, 2021