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Removal of Lung Nodules After Being Marked With a Microcoil

Thoracoscopic Resection of Subcentimetre Lung Nodules After Localization Using Percutaneous Inserted Platinum Microcoil Under CT Guidance: a Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00323089
Enrollment
151
Registered
2006-05-09
Start date
2003-04-30
Completion date
2017-12-30
Last updated
2018-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

microcoil, subcentimetre nodules

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.

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%.

Interventions

PROCEDUREmicrocoil 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.

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Preoperative CT-Guided Microcoil Localization (CTML) and Fluoroscopic-Guided Video-Assisted Thoracoscopic (VATS) Wedge Resection of Small Peripheral Pulmonary Nodules (SPPN)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* subcentimetre lung nodule

Design outcomes

Primary

MeasureTime frameDescription
pulmonary nodule excision with microcoil6 yearsThoracotomy and excision rates

Secondary

MeasureTime frameDescription
Recurrence and death from lung cancer10 yearsDeath or CT recurrence of lung cancer

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026