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Removal of Lung Nodules After Being Marked With a Microcoil

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ClinicalTrials.gov Identifier: NCT00323089
Recruitment Status : Completed
First Posted : May 9, 2006
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Richard Finley, University of British Columbia

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.


Condition or disease Intervention/treatment
Lung Cancer Procedure: microcoil insertion and excision

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%.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Preoperative CT-Guided Microcoil Localization (CTML) and Fluoroscopic-Guided Video-Assisted Thoracoscopic (VATS) Wedge Resection of Small Peripheral Pulmonary Nodules (SPPN)
Masking: None (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
Study Start Date : April 2003
Primary Completion Date : December 30, 2017
Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Surgical Arm
Preoperative CT-Guided Microcoil Localization (CTML) and Fluoroscopic-Guided Video-Assisted Thoracoscopic (VATS) Wedge Resection of Small Peripheral Pulmonary Nodules (SPPN)
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.



Primary Outcome Measures :
  1. pulmonary nodule excision with microcoil [ Time Frame: 6 years ]
    Thoracotomy and excision rates


Secondary Outcome Measures :
  1. Recurrence and death from lung cancer [ Time Frame: 10 years ]
    Death or CT recurrence of lung cancer



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subcentimetre lung nodule

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323089


Locations
Canada, British Columbia
Richard Finley
Vancouver, British Columbia, Canada, V7V3A2
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Richard Finley, MD The University of British Columbia

Responsible Party: Richard Finley, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT00323089     History of Changes
Other Study ID Numbers: H02-70562
04-0048 ( Other Grant/Funding Number: BC Lung Association )
20R42080 ( Other Grant/Funding Number: BC Lung Association )
First Posted: May 9, 2006    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Richard Finley, University of British Columbia:
microcoil
subcentimetre nodules