Percutaneous Image Guided Video-Assisted Thoracic Surgery (VATS) Resection of Lung Lesions

Phase 2

Completed

• Conditions: Lung Cancer
• Interventions: Procedure: Video-Assisted Thoracic Surgery (VATS) wedge resection

• Registration Number: NCT01847209
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

This is a phase II protocol to determine the safety and feasibility of Intraoperative CT fluoroscopy guidance for lung resection for small nodules.

Detailed Description

This is a phase II protocol to determine the safety and feasibility of image guided CT marking for resection of small lung nodules. This is relevant because many such nodules are hard to localize for minimally invasive lung resection. It is hoped that this technology using fluoro CT capability available now in most operating room will improve safety and reliability of thoracic surgery.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-02
• Study First Submitted QC: 2013-05-03
• Study First Posted: 2013-05-06
• Primary Completion: 2014-09
• Results First Submitted: 2017-01-04
• Study Completion: 2017-12
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-29
• Last Update Submitted: 2019-01-29
• Results First Posted: 2019-04-29
• Last Update Posted: 2019-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• peripheral lung nodules < 3cm in size
• Surgical candidate

Exclusion Criteria

• Non surgical candidate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CT Marking and VATS lung wedge resection	Video-Assisted Thoracic Surgery (VATS) wedge resection	Each patient with a lung nodule meeting criteria will undergo marking with fiducials followed at the same time by Video-Assisted Thoracic Surgery (VATS) lung wedge resection under CT fluoroscopy.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	30 days	The patient will be monitored while in the hospital by their thoracic surgical team as well as by two research nurses named Lauren Donahue, RN and Karen Magsipoc, NP. The research nurses will document any perioperative complications and mortality that arise during the patient's stay in the hospital.

Secondary Outcome Measures

Name	Time	Method
Patients Underwent a Successful Resection	30 days	Number of patients who underwent a successful resection which is measured by an accurate and appropriate resection in a given timeline

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States