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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%

Phase 3
19 Years
Open (Enrolling)
Lung Cancer

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Trial Information

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.

Inclusion Criteria:

Patients will be evaluated for eligibility using the following

- All newly diagnosed patients with small lung nodules < 1cm that require excision with
no history of prior ipsilateral thoracotomy.

- The nodules must be located in parts of the lung that are amenable to thoracoscopic
wedge excision of the nodules.The external surface of the lesion must be at least 2
cm from the major pulmonary arteries, veins, and main bronchi to allow safe and
adequate thoracoscopic excision of the lesion.

- Patients must be mentally competent to give written, informed consent

- Patients must be capable of independently completing standard English-language QOL

Exclusion Criteria:

- Patients will be excluded from the trial if they do not consent to participate in the
study, or if the radiologist and surgeon agree that the nodule is located too
centrally to be safely excised using thoracoscopic wedge techniques.

- Patients with more than three nodules will be excluded from the study.

- Patients with a positive diagnosis of non-small cell lung cancer obtained from sputum
cytology, bronchoscopy, or CT guided needle biopsy will be excluded from the study.

- If the patient is excluded, he/she will receive the current standard treatment, which
may include needle biopsy, continued observation of the nodule at three to six
monthly intervals, or excisional surgery (thoracoscopy or open thoracotomy).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

conversion to open thoracotomy

Outcome Time Frame:

final surgery June15, 2012

Safety Issue:


Principal Investigator

Richard Finley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of British Columbia


Canada: Health Canada

Study ID:




Start Date:

January 2010

Completion Date:

June 2013

Related Keywords:

  • Lung Cancer
  • subcentimetre nodules
  • Lung Neoplasms