Study to See if Microcoil Insertion Reduces the Rate of Open Thoracotomy for Removal of Lung Nodules

NCT01028417 | Completed Phase 3

• 1 other identifier: H09-02265
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

LAY ABSTRACT

1. 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. 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.
2. 2.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.
3. 3.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%.
4. 4.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
5. 5.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.

Conditions

Lung Cancer

Keywords

subcentimetre nodules

Outcome Measures

Primary Outcomes (1)

• conversion to open thoracotomy

  final surgery June15, 2012

Secondary Outcomes (3)

• the quality of life using well-validated quality of life instruments

  last date July 15, 2013

• the preoperative, intraoperative and postoperative costs

  end: July 15, 2013

• the perioperative morbidity and mortality

  last date June 15, 2012

Study Arms (2)

Group 1

EXPERIMENTAL

Group 1 receives the intervention - insertion of platinum microcoil followed by nodule excision

Device: Platinum microcoil

Group 2

NO INTERVENTION

Group 2 receives the standard of care - nodule excision, but without the microcoil insertion

Interventions

Platinum microcoil DEVICE

Coil Name: Vortx-18, Diamond Shape, Boston Scientific, Cork, Ireland; Coil Description: 80 mm long, fibre coated 0.018 inch diameter platinum microcoil

Group 1

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All newly diagnosed patients with small lung nodules \< 1cm that require excision with no history of prior ipsilateral thoracotomy.
• The nodules must be located in parts of the lung that are amenable to thoracoscopic wedge excision of the nodules.The external surface of the lesion must be at least 2 cm from the major pulmonary arteries, veins, and main bronchi to allow safe and adequate thoracoscopic excision of the lesion.
• Patients must be mentally competent to give written, informed consent
• Patients must be capable of independently completing standard English-language QOL instruments.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital - Diamond Pavilion

Vancouver, British Columbia, Canada

Location

Related Publications (1)

• 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.

  PMID: 25293355 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Richard Finley, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• John Mayo

  University of British Columbia

  STUDY DIRECTOR

• Joanne Clifton

  University of British Columbia

  STUDY DIRECTOR

• John Yee

  University of British Columbia

  STUDY DIRECTOR

• Ken Evans

  University of British Columbia

  STUDY DIRECTOR

• John English

  University of British Columbia

  STUDY DIRECTOR

• Larry Lynd

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 9, 2009
• Study Start: January 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: October 1, 2013
• Last Updated: March 3, 2014

Record last verified: 2012-07

Locations

CA (1)