Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00323089
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2006-05-08
Brief Title:
Removal of Lung Nodules After Being Marked With a Microcoil
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Thoracoscopic Resection of Subcentimetre Lung Nodules After Localization Using Percutaneous Inserted Platinum Microcoil Under CT Guidance a Pilot Study
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 cure1 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 802 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 853 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 malignant4 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-0048 | OTHER_GRANT | None | None |
| 20R42080 | OTHER_GRANT | BC Lung Association | None |