Efficacy Assessment of CT-guided Hook Wire Localization of Lung Nodes Before Thoracoscopy

NCT02648594 | Withdrawn Phase 2

• 1 other identifier: 2015-A00958-41
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

When patient presents a lung node, there is an important risk that this node was a tumor. For patients who have these nodes, the surgery is the best treatment. When the surgery is possible, the thoracoscopy may be more advantageous compared to thoracothomy (decrease of post surgery pains, decrease of recovery time and decrease of drugs consumption). Nevertheless, thoracoscopy needs specific materiels and nécessite un équipement spécifique and trained physicians. Moreover, this technic needs that nodes was well localized. For this, radiologists use CT-guided hook wire localization of these lung nodes before surgery. TThe hook wire laying is delicate. It can lead secondaries effects as pneumothorax, dislodgement of the hook wire before and after surgery. The success rate of hook wire fixation in lung near of the node is primary. The main objective of our study is to assess the success rate localization of node in surgery piece, that is to verify if the hook wire have allowed to localize the lung node in surgery piece.

Conditions

Nodes, Lung

Keywords

lung; thoracoscopy; hook wire localization

Outcome Measures

Primary Outcomes (1)

• Nodule detection in surgery piece (success rate)

  At surgery

Secondary Outcomes (2)

• Nodule detection under scanner

  After patient inclusion, at scan realisation, before surgery. This detection will be realised up to 4 weeks after inclusion.

• Adverse events assessment graded with NCI -CTCAE v4.0

  Before and after surgery, up to 4 weeks after surgery

Study Arms (1)

Intervention: Hook wire CT guided

EXPERIMENTAL

There is only one arm. When patient undergo surgery , the radiologist will place a CT-guided Hook wire in order to localize it in patient lung. The intervention consists to place a CT-guided hook wire in contact with the pulmonary nodule under local anesthesia. Then, the thoracoscopy will be realised. Then, the surgery piece will be examined to confirm if the node is in the surgery piece

Device: Hook wire CT guided

Interventions

Hook wire CT guided DEVICE

The intervention consist to place a CT-guided hook wire in lung patient

Intervention: Hook wire CT guided

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years
• Patient with suspect lung node, needed surgery
• Signed consent

You may not qualify if:

• Too deep node
• Severe co-morbidities : respiratory insufficiency, cardiac insufficiency
• Major emphysema
• Patient with only one lung
• Pregnant women
• Breastfeeding women
• Patient with cognitive and psychiatric troubles

Sponsors & Collaborators

• Centre Jean Perrin: lead

Study Sites (1)

Centre Jean Perrin

Clermont-Ferrand, 63000, France

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: January 7, 2016
• Study Start: October 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: January 24, 2018

Record last verified: 2018-01

Locations

FR (1)