Lung CancerPhase 3NCT01028417
Study to See if Microcoil Insertion Reduces the Rate of Open Thoracotomy for Removal of Lung Nodules
A Phase 3 study testing Platinum microcoil in people with Lung Cancer, run by University of British Columbia at 1 site in Canada.
Trial summary
LAY ABSTRACT 1. Statement of the health problem or issue: Of the estimated 24,000 Canadians who will be diagnosed with lung cancer in 2008, 21,000 will die of their disease. Based on this cancer incidence and survival data, the most promising current strategy for improving outcome is screening and early detection. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Platinum microcoil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Oct 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver General Hospital - Diamond Pavilion
Vancouver, British Columbia
About this study
Official title: 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%
LAY ABSTRACT
- Statement of the health problem or issue: Of the estimated 24,000 Canadians who will be diagnosed with lung cancer in 2008, 21,000 will die of their disease. Based on this cancer incidence and survival data, the most promising current strategy for improving outcome is screening and early detection. It is suggested that if lesions are discovered at an earlier stage of disease, they will have a higher likelihood of being treatable and therefore, survival will be improved. CT detection of growing small lung nodules, many of which are non-cancerous (benign), raises the possibility of lung cancer and thus causes anxiety in patients and referring clinicians. Unfortunately, confident separation of benign from malignant small lung nodules cannot be reliably achieved using CT or PET criteria. Pathologic diagnosis using needle or excision biopsy is usually required. Excision biopsy removes the entire nodule at one setting and eliminates the sampling error associated with needle biopsy, making it appealing to physicians and patients. To reduce post-operative pain and breathing difficulties, excision biopsy is often performed using minimally invasive surgery (video assisted thoracoscopic surgery, VATS). Finding small pulmonary nodules is often difficult with the minimally invasive camera (VATS) and a bigger incision (thoracotomy) is necessary in more than 60% of our patients. We recently developed a technique of using platinum micro-coils, which are inserted in the lung nodule using CT guidance, to locate the nodule with fluoroscopy and then excise it with VATS. We have completed a pilot study (n=75 nodules; 69 patients) to determine the effectiveness of this technique. Seventy three (97%) 4-24-mm nodules were successfully removed at fluoroscopically guided VATS excision.
- Objective of your project: To improve our ability to successfully excise small growing lung nodules with minimally invasive VATS surgery using CT guided micro-coil localization techniques.
- How will you undertake your work? We propose to conduct a randomized controlled trial to determine if the use of CT guided platinum microcoil markers for VATS excision of subcentimetre pulmonary nodules can reduce the rate of conversion to open thoracotomy from 50% to 10%.
- What is unique/innovative about your project? New image guided minimally invasive surgical technique for removing early growing cancers was developed at the Vancouver General Hospital and the University of British Columbia. This has been published in peer-reviewed journals and can potentially allow us to accurately locate and excise suspicious lung nodules
- Relevance to Lung Association's mission statement? Lung cancer remains a major health problem in Canada. Early detection and screening programs allow for discovery of nodules when they are still very small and therefore, likely curable. Excision biopsy removes the entire nodule at one setting and eliminates the sampling error associated with needle biopsy, making it appealing to patients and physicians. To reduce post operative morbidity, costs and volume of lung removed, excision biopsy is often performed using video assisted thoracoscopic surgery (VATS) techniques. Using a pilot project grant from the BC Lung Association we have developed a new technique that allows preoperative CT marking of the nodule and minimally invasive removal of the lesion. We hope that this technique will allow earlier treatment of lung cancers and improve survival in this devastating disease.
Read the detailed description
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.
- Conditions
- Lung Cancer
- Being tested
- Platinum microcoil
- Keywords
- subcentimetre nodules
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platinum microcoilDevice
Coil Name: Vortx-18, Diamond Shape, Boston Scientific, Cork, Ireland; Coil Description: 80 mm long, fibre coated 0.018 inch diameter platinum microcoil
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1 receives the intervention - insertion of platinum microcoil followed by nodule excision Receives: Device: Platinum microcoil |
| Group 2 | No intervention | Group 2 receives the standard of care - nodule excision, but without the microcoil insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
conversion to open thoracotomy
Measured: final surgery June15, 2012
Secondary outcomes (3)
the quality of life using well-validated quality of life instruments
Measured: last date July 15, 2013
the preoperative, intraoperative and postoperative costs
Measured: end: July 15, 2013
the perioperative morbidity and mortality
Measured: last date June 15, 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJun 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Finley, MD, Principal investigator, University of British ColumbiaJohn Mayo, Study director, University of British ColumbiaJoanne Clifton, Study director, University of British ColumbiaJohn Yee, Study director, University of British ColumbiaKen Evans, Study director, University of British ColumbiaJohn English, Study director, University of British ColumbiaLarry Lynd, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028417
- Sponsor's protocol ID
- H09-02265
- Status last verified
- Jul 2012
- First submitted
- 3 Dec 2009
- Last updated
- 3 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Finley RJ, Mayo JR, Grant K, Clifton JC, English J, Leo J, Lam S. Preoperative computed tomography-guided microcoil localization of small peripheral pulmonary nodules: a prospective randomized controlled trial. J Thorac Cardiovasc Surg. 2015 Jan;149(1):26-31. doi: 10.1016/j.jtcvs.2014.08.055. Epub 2014 Sep 16.
PubMed 25293355
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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%
- ClinicalTrials.gov ID
- NCT01028417
- Acronym / sponsor ID
- H09-02265
- Conditions
- Lung Cancer
- Keywords
- subcentimetre nodules
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
LAY ABSTRACT
- Statement of the health problem or issue: Of the estimated 24,000 Canadians who will be diagnosed with lung cancer in 2008, 21,000 will die of their disease. Based on this cancer incidence and survival data, the most promising current strategy for improving outcome is screening and early detection. It is suggested that if lesions are discovered at an earlier stage of disease, they will have a higher likelihood of being treatable and therefore, survival will be improved. CT detection of growing small lung nodules, many of which are non-cancerous (benign), raises the possibility of lung cancer and thus causes anxiety in patients and referring clinicians. Unfortunately, confident separation of benign from malignant small lung nodules cannot be reliably achieved using CT or PET criteria. Pathologic diagnosis using needle or excision biopsy is usually required. Excision biopsy removes the entire nodule at one setting and eliminates the sampling error associated with needle biopsy, making it appealing to physicians and patients. To reduce post-operative pain and breathing difficulties, excision biopsy is often performed using minimally invasive surgery (video assisted thoracoscopic surgery, VATS). Finding small pulmonary nodules is often difficult with the minimally invasive camera (VATS) and a bigger incision (thoracotomy) is necessary in more than 60% of our patients. We recently developed a technique of using platinum micro-coils, which are inserted in the lung nodule using CT guidance, to locate the nodule with fluoroscopy and then excise it with VATS. We have completed a pilot study (n=75 nodules; 69 patients) to determine the effectiveness of this technique. Seventy three (97%) 4-24-mm nodules were successfully removed at fluoroscopically guided VATS excision.
- Objective of your project: To improve our ability to successfully excise small growing lung nodules with minimally invasive VATS surgery using CT guided micro-coil localization techniques.
- How will you undertake your work? We propose to conduct a randomized controlled trial to determine if the use of CT guided platinum microcoil markers for VATS excision of subcentimetre pulmonary nodules can reduce the rate of conversion to open thoracotomy from 50% to 10%.
- What is unique/innovative about your project? New image guided minimally invasive surgical technique for removing early growing cancers was developed at the Vancouver General Hospital and the University of British Columbia. This has been published in peer-reviewed journals and can potentially allow us to accurately locate and excise suspicious lung nodules
- Relevance to Lung Association's mission statement? Lung cancer remains a major health problem in Canada. Early detection and screening programs allow for discovery of nodules when they are still very small and therefore, likely curable. Excision biopsy removes the entire nodule at one setting and eliminates the sampling error associated with needle biopsy, making it appealing to patients and physicians. To reduce post operative morbidity, costs and volume of lung removed, excision biopsy is often performed using video assisted thoracoscopic surgery (VATS) techniques. Using a pilot project grant from the BC Lung Association we have developed a new technique that allows preoperative CT marking of the nodule and minimally invasive removal of the lesion. We hope that this technique will allow earlier treatment of lung cancers and improve survival in this devastating disease.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Platinum microcoilGroup 1 receives the intervention - insertion of platinum microcoil followed by nodule excision |
| Group 2 | No intervention | –Group 2 receives the standard of care - nodule excision, but without the microcoil insertion |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platinum microcoilCoil Name: Vortx-18, Diamond Shape, Boston Scientific, Cork, Ireland; Coil Description: 80 mm long, fibre coated 0.018 inch diameter platinum microcoil | Device | Group 1 |
Primary outcome
conversion to open thoracotomy
Time frame: final surgery June15, 2012
3 secondary outcomes
the quality of life using well-validated quality of life instruments
Time frame: last date July 15, 2013
the preoperative, intraoperative and postoperative costs
Time frame: end: July 15, 2013
the perioperative morbidity and mortality
Time frame: last date June 15, 2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2014.
- Derived from this study: PubMed 25293355Finley RJ, Mayo JR, Grant K, Clifton JC, English J, Leo J, Lam S. Preoperative computed tomography-guided microcoil localization of small peripheral pulmonary nodules: a prospective randomized controlled trial. J Thorac Cardiovasc Surg. 2015 Jan;149(1):26-31. doi: 10.1016/j.jtcvs.2014.08.055. Epub 2014 Sep 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Finley, MD principal investigator
University of British Columbia
John Mayo study director
University of British Columbia
Joanne Clifton study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Platinum microcoil in people with Lung Cancer, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
conversion to open thoracotomy (time frame: final surgery June15, 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01028417, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2014; AzTrials last refreshed its copy on 31 Oct 2026.