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WithdrawnNCT02648594HARNOUpdated Jan 24, 2018

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

A Phase 2 interventional study of Hook wire CT guided in Nodes, Lung, sponsored by Centre Jean Perrin. Withdrawn at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-24.

Sponsored by Centre Jean Perrin · Phase 2, Interventional, and Diagnostic

Why this study was withdrawn
A retrospective study has already been conducted on the same topic
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

For lung cancer patients, the best treatment remains the surgery when tumor is localized.

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. In France, only 1% of surgeries qu'en France, thoracoscopy represents less than 1% of lung cancer surgeries while it represents 30% of interventions in Japan.

Moreover, this technic needs that nodes was well localized. For this, radiologists use CT-guided hook wire localization of these lung nodes before surgery.

According to the litterature, this localization technic is efficient (Chen et al, 2011).

The 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. This implies that:

  • the hook wire was well CT-guided in the lung
  • the hook wire did not present a dislodgment before or during surgery
  • the hook wire is near of the node to be removed Among secondaries objectives, the investigators will assess the safety and possible complications which could occur. The investigators will also measure the distance between hook wire and center of the node
02

Conditions studied

  • Nodes, Lung

Keywords

  • lung
  • thoracoscopy
  • hook wire localization
03

In context

Lead sponsor

Centre Jean Perrin is the lead sponsor of 55 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Intervention: Hook wire CT guided

    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

  • DeviceHook wire CT guided

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

06

What researchers measure

Primary outcomes

  1. Nodule detection in surgery piece (success rate)

    Time frame: At surgery

Secondary outcomes

  1. Nodule detection under scanner

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

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

    Time frame: Before and after surgery, up to 4 weeks after surgery

07

Study locations

1 site
  • Centre Jean Perrin
    Clermont-Ferrand, 63000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02648594
Lead sponsor
Centre Jean Perrin
Responsible party
Sponsor
First posted
Jan 7, 2016
Start date
Oct 2016
Primary completion
May 2017
Completion
May 2017
Last update
Jan 24, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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