Removal of Lung Nodules After Being Marked With a Microcoil
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Purpose
The objective of this study is to determine if subcentimetre pulmonary nodules can be accurately and safely excised by endoscopic stapling devices after they have been localized using CT and marked with a microcoil device.
The addition of real-time CT imaging and insertion of platinum microcoil markers to the technique of video assisted thoracoscopic stapled resection of subcentimetre pulmonary nodules, will decrease the rate of open thoracotomies required to completely resect the nodules.
| Condition | Intervention |
|---|---|
|
Lung Cancer |
Procedure: microcoil insertion and excision |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Thoracoscopic Resection of Subcentimetre Lung Nodules After Localization Using Percutaneous Inserted Platinum Microcoil Under CT Guidance: a Pilot Study |
- pulmonary nodule excision with microcoil [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- time [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Surgical Arm |
Procedure: microcoil insertion and excision
The objective of this study is to determine if subcentimetre pulmonary nodules can be accurately and safely excised by endoscopic stapling devices after they have been localized using CT and marked with a microcoil device.
|
Detailed Description:
Lung cancer is the most common cause of cancer death for both men and women in the industrialized world. Small cell lung cancer accounts for about 25% of lung cancers and is usually widespread when it first presents. The remaining 75% of lung cancers are collectively termed non-small cell lung cancers. When presentation is by symptoms or incidental discovery, about 50 to 60% of non-small cell lung cancers are parenchymal nodules or masses and 40 to 50% are bronchial or hilar. More than 50% of patients with non-small cell cancer will have distant metastases at the time of diagnosis and only 25% will be potentially resectable for cure.1 Overall survival at five years for lung cancer is approximately 15% and has not significantly improved over the last several decades. Prognosis for lung cancer is affected by many factors but one of the most important is the stage of the disease at presentation. Individuals with peripheral lesions less than 3 cm in diameter (T1) at presentation are ideal candidates for surgical resection and have the best outcomes, with 5-year survival rates as high as 60 to 80%.2 Patients with small subcentimeter pulmonary nodes may have even better survival with resection. Computed tomography can now detect cancers less than 4 mm in diameter, and it has been shown that resection of subcentimetre lung cancers results in a survival rate of up to 85%.3 However, Suzuki et al found 54% of 92 patients undergoing video assisted thoracoscopic excision of subcentimetre nodules, required conversion to a thoracotomy. Forty percent of those nodules were found to be malignant.4 The most common reason for this conversion was failure to localize the nodule using thoracoscopic visualization or palpation. Furthermore, univariate and multivariate analysis of eleven variables revealed that if the distance from the pleural surface was greater than 5 mm, the probability of failure to detect the nodule was 63%.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- subcentimetre lung nodule
Exclusion Criteria:
Contacts and Locations| Contact: Joanne Clifton, MSc | 604-875-5355 | joanne.clifton@vch.ca |
| Canada, British Columbia | |
| Vancouver General Hospital Department of Surgery | Recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Joanne Clifton, MSc. 604-875-5355 joanne.clifton@vch.ca | |
| Principal Investigator: Richard Finley, MD | |
| Principal Investigator: | Richard Finley, MD | The University of British Columbia |
More Information
No publications provided
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00323089 History of Changes |
| Other Study ID Numbers: | C02-0562, 04-0048 |
| Study First Received: | May 8, 2006 |
| Last Updated: | September 5, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
microcoil subcentimetre nodules |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013