A Randomized Controlled Trial To Determine If Thoracoscopic Resection Of Subcentimetre Lung Nodules After Localization Using Percutaneously Inserted Platinum Microcoils Under CT Guidance Reduces Rate Of Conversion To Open Thoracotomy From 50% To 10%
Intervention Description:
The pre-operative CT scan will be reviewed by the surgeon with the radiologist to determine
if the nodule can be excised using thoracoscopic staple wedge techniques. After informed
consent, the patient will be seen by an anesthesiologist to determine risks and benefits of
a general anesthetic. The patient will initially come to the CT scanner suite in the
radiology department. The CT guided percutaneous microcoil nodule localization procedure,
will be performed consciously under local anaesthesia Using sterile technique and local
anesthetic, a biopsy needle (22 gauge) pre-loaded with an 6 cm long platinum microcoil will
be placed 10mm deep to the suspicious pulmonary nodule using CT guidance. The coil will be
deployed such that one end will be adjacent to the nodule and the other end will lie free on
the: lung surface. The patient will be transferred to the Laurel OR where they will be
placed under general anesthesia with a double lumen endotracheal tube in order to allow
collapse of the involved lung during the thoracoscopic excision of the marked lung nodule.
The patient's blood pressures, oxygen levels, pulse and ECG will be monitored. The
thoracoscopic excision of the nodule will be performed using the microcoil as a localizing
device. Using the preoperative CT scan, the study surgeon will mark the insertion sites
for thoracoscopic instruments. Instruments for video-assisted thoracoscopy include a rigid 5
mm thoracoscope, a light source, a video-camera and monitor, and 5 mm grasping forceps. The
patient will be draped. A 5mm thoracoscopic port is inserted into the thorax percutaneously
and the lung is examined with the thoracoscope. The nodule location will be identified by
the end of the microcoil that sits on the surface of the lung. A second 5 mm port is put in
place and the end of the microcoil grasped under thoracoscopic visualization. Multiple
endoscopic are placed via a third 12mm port and the nodule and coil are completely excised
under fluoroscopic guidance. The resected nodule is placed in an endoscopic bag and brought
out through the large port site. If the lesion cannot be excised by the VATS technique the
patient will undergo an open rib spreading thoracotomy for excision of the marked nodule.
The indications for thoracotomy at this time are:poor visualization of the lung, pleural
symphysis with scarring, uncontrollable bleeding or inability to completely resect the
lesion with the thoracoscopic endostapler.
The specimen is sent for frozen section pathological examination. If the lesion is benign
the thoracic cavity is irrigated with saline and a small chest tube is put in place and
attached to under water drainage. The incisions are then closed and the lung is re-expanded.
The patient is then transported to the post-anesthetic room similar to other patients
undergoing general anesthesia. If the lesion is a non-small cell cancer of the lung the
patient may undergo a sampling of lymph nodes at that time followed by formal lobectomy. If
the patient has inadequate pulmonary function to tolerate a lobectomy and the lesion has
been completely excised the surgeon may choose to stop the operation at that time and follow
the patient.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
conversion to open thoracotomy
final surgery June15, 2012
No
Richard Finley, MD
Principal Investigator
University of British Columbia
Canada: Health Canada
H09-02265
NCT01028417
January 2010
June 2013
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