Image Guided VATS vs. VATS Resection

Lung Cancer Clinical Trial

Official title:

Image Guided VATS Resection vs. VATS Resection of Lung Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03623958
• Other study ID #: 2017P000291
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Brigham and Women's Hospital
• Contact: Julianne S Barlow
• Phone: 617-525-8704
• Email: jbarlow1[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate workflow and outcomes of iVATS and standard VATS for small pulmonary nodules. The outcomes of the patients will be evaluated separately as there will be no direct comparison of the two arms.

Description:

This is a prospective phase II clinical study to evaluate iVATS and standard VATS for small pulmonary nodules. We have successfully completed and published a phase I/pilot study with 25 patients demonstrating safety and optimal procedural workflow for combining image-guidance with VATS. This phase II clinical study will further expand upon the safety and feasibility of this procedure. Additionally, this data will be used to design a phase III comparison study between iVATS and standard VATS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject must be 18 years and older

• Subject must be deemed a candidate for the iVATS surgery, by their treating Thoracic Surgeon

• Subject must have nodules/GGO or other abnormal opacity that can be accurately measured in at least one dimension with longest diameter = 20 mm or 2cm

• Subject's lesions that are located in the outer half portion of the lung/lobe.

• Subjects must be evaluated at BWH and/or DFCI Thoracic Surgery outpatient clinics

Exclusion Criteria:

• If participant is a pregnant woman or breast feeding they will not be eligible.

• If treating thoracic surgeon deems the participant not eligible for the study.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Device:
• Image guided Video-Assisted Thoracic Surgery (VATS) resection
Image guided placement of a fiducial consisting of a needle directed placement of a T-Bar next to the target lesion in order to lead the surgeon to the lung region to be removed

Procedure:
• Video-Assisted Thoracic Surgery
Standard of Care Video-Assisted Thoracic Surgery (VATS) resection

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gill RR, Zheng Y, Barlow JS, Jayender J, Girard EE, Hartigan PM, Chirieac LR, Belle-King CJ, Murray K, Sears C, Wee JO, Jaklitsch MT, Colson YL, Bueno R. Image-guided video assisted thoracoscopic surgery (iVATS) - phase I-II clinical trial. J Surg Oncol. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quantitative Analysis of CT scans	To collect imaging data from pre-operative and post-operative CT scans for quantitative analysis from both arm.	3 years
Primary	Operating Room Time	The time (in min.) from incision to close	3 years to complete
Secondary	Time to T-bar placement	The time from patient ready for surgery to placement of t-bar	3 years
Secondary	Time for induction to incision	Time (in min) from induction to incision made	3 years
Secondary	Hospital Length of Stay	Length of hospital stay (in days) in both arms	3 years
Secondary	Radiation Exposure	The radiation exposure (mSV) in the iVATS arm	3 years