ENB Robotic ICG Guided Surgery: A Novel Technique for Targeting Small Lung Tumors
Status:
Withdrawn
Trial end date:
2017-10-01
Target enrollment:
Participant gender:
Summary
Lung cancer is the leading cause of cancer deaths worldwide. However, if diagnosed at an
early stage (tumor <2 cm), lung cancer is highly curable with a 5-year survival rate greater
than 80% after surgical resection. Screening tests have made it easier to identify small lung
tumors. However, these tumors are often not visible to the naked eye, and surgeons cannot
feel them, making them difficult to precisely locate and remove. For this reason, surgeons
have become more reliant on image guided surgery for the removal of these tumors.
The standard of care for locating and removing small lung tumors is microcoil-guided
video-assisted thoracoscopic surgery (VATS). This is a two-step procedure performed by two
separate physicians.
- First, patient is taken to radiology suite and radiologist inserts a microcoil near the
lung tumor
- Second (usually occurs a few hours later), patient is taken to operating room; a surgeon
uses an x-ray arm to find the microcoil within the lung and remove it surgically.
A pathologist reviews the resected tissue to make sure that the tumor and the microcoil were
both removed. Until this evaluation, the surgeon does not know whether the tumor has been
removed or not. While this method is safe, it is time consuming, uses staff resources, and
requires bulky equipment to complete.
In this study, we plan to develop and test a new method of identifying and removing small
lung tumors. This procedure is called Electromagnetic Navigational Bronchoscopy (ENB) Robotic
Indocyanine Green Guided Surgery (RIGGS) or ENB-RIGGS for a short name. The purpose of this
study is to test the safety and reliability of the ENB-RIGGS surgery in the form of a pilot
study.
ENB-RIGGS surgery is done in the operating room by a surgeon under general anesthetic.
ENB-RIGGS begins by creating a 3-D GPS map of the lung which guides the surgeon directly to
the tumor. A fluorescent green dye called indocyanine green is then injected into the tumor,
and when viewed by the special robotic camera the tumour will fluoresce with a green hue
allowing the surgeon to easily see the tumour. The surgeon then uses the robot to remove the
tumor and surrounding tissue. The lung tissue specimen will be evaluated immediately by a
pathologist.