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

Nodes, Lung Clinical Trial

— HARNO  

Official title:

Efficacy Assessment of CT-guided Hook Wire Localization of Lung Nodes With Medical Device " Fil d'Ariane " Laurane médical Before Thoracoscopy- HARNO Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02648594
• Other study ID #: 2015-A00958-41
• Status: Withdrawn
• Phase: Phase 2
• First received: December 23, 2015
• Last updated: January 23, 2018
• Start date: October 2016
• Est. completion date: May 2017

Study information

• Verified date: January 2018
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Patient with suspect lung node, needed surgery

• Signed consent

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

Related Conditions & MeSH terms

• Nodes, Lung

Intervention

Device:
• Hook wire CT guided
The intervention consist to place a CT-guided hook wire in lung patient

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nodule detection in surgery piece (success rate)		At surgery
Secondary	Nodule detection under scanner		After patient inclusion, at scan realisation, before surgery. This detection will be realised up to 4 weeks after inclusion.
Secondary	Adverse events assessment graded with NCI -CTCAE v4.0		Before and after surgery, up to 4 weeks after surgery