Efficacy Assessment of CT-guided Hook Wire Localization of Lung Nodes With Medical Device " Fil d'Ariane " Laurane médical Before Thoracoscopy- HARNO Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Nodule detection in surgery piece (success rate)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Patient with suspect lung node, needed surgery
- •Signed consent
排除标准
- •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
研究组 & 干预措施
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
干预措施: Hook wire CT guided (Device)
结局指标
主要结局
Nodule detection in surgery piece (success rate)
时间窗: At surgery
次要结局
- Adverse events assessment graded with NCI -CTCAE v4.0(Before and after surgery, up to 4 weeks after surgery)
- Nodule detection under scanner(After patient inclusion, at scan realisation, before surgery. This detection will be realised up to 4 weeks after inclusion.)