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

NCT ID: NCT02648594

Last Updated: 2018-01-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-05-31

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.

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

Conditions

Nodes, Lung

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Hook wire CT guided

Intervention Type: DEVICE

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

Interventions

Hook wire CT guided

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Jean Perrin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Jean Perrin

Clermont-Ferrand, , France

Countries

France

Other Identifiers

2015-A00958-41

Identifier Type: -

Identifier Source: org_study_id