Feasibility Study on the Contribution of Guided Puncture With Echoendoscopy in Evaluation of Hypermetabolic Lymphadenopathy Mediastinum Lower, Rear and Middle, Detected in PET-CT to 18 FDG (PET)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Sensitivity of Endoscopic Ultrasound-guided (EUS-guided) Puncture
研究概览
简要总结
Impact of screening nodes mediastinal by PET, at different times of the management of cancer disease, remain unclear.
Benefits of combined PET and puncture with echoendoscopy for the diagnosis subsequent therapeutic management should be evaluated in these different contexts.
We would like to demonstrate the clinical utility of this association to replace more invasive diagnostic procedures and to assess the impact of the puncture on a possible modification of the therapeutic management.
It is a single center prospective diagnostic assessment
详细描述
Main objective :
Assess the performance (in terms of sensitivity) of guided punction by echoendoscopy in the characterization of hypermetabolic mediastinal lymph nodes in PET, in a context of New cancer or cancer recurrence.
Conduct of the study :
When a patient has had a PET scan showing a hypermetabolic or mediastinal lymph nodes in the lower, middle or posterior, his case is presented in a multidisciplinary meeting (PCR # 1), with definition of diagnostic strategy:
Approved indication is achieve a biopsy surgically to have a histological documentation of mediastinal lymph nodes with obvious impact on treatment decisions.
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
- •Any patients who have had PET showing one or more hypermetabolic lymphadenopathy in middle mediastinum and/or lower and/or posterior, and requiring diagnostic certainty for support.
- •PET scans performed in these particulars :
- •Pre-treatment assessment of thoracic or extra-thoracic malignancies (patients without a history of cancer).
- •Evaluation of response to treatment referred to oncological.
- •Suspicion of relapse in patients with a personal history of thoracic or extra-thoracic malignancies.
- •PET, the result is positive :
- •For above-centimeter lymph node short axis: greater result than or equal to the background hepatic noise.
- •For sub-centimeter lymph node small axis : greater result than the background hepatic noise
- •Patient with indication of diagnostic procedure surgically (whether realized or not)
- •Lymph node(s) available(s) puncture by EUS esophageal, so for a technically feasible for esophageal puncture (without vascular recusants structures)
- •Age ≥ 18 years.
- •PET scan performed within 6 weeks before EUS
- •Platelets ≥ 70 000/mm3; TP ≥ 60%.
- •Patient of childbearing age with negative pregnancy test and / or a contraception.
- •Patient gave informed consent signed.
- •Patient affiliated to a social security scheme.
排除标准
- •Contra-indication (s) Director (s) to achieve a EUS.
- •Balance adverse anesthetic (not allowing a general anesthetic).
- •Esophageal stenosis.
- •Coagulation disorders.
- •Pregnant or lactating women.
- •Unable to undergo medical monitoring test for geographical, social or psychological reasons.
- •Private patient freedom and major subject of a measure of legal protection or unable to consent.
研究组 & 干预措施
hypermetabolic mediastinal lymph nodes in PET,
hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence.
干预措施: Guided punction of mediastinal lymphadenopathy by echoendoscopy (Procedure)
hypermetabolic mediastinal lymph nodes in PET,
hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence.
干预措施: PET scan (Device)
结局指标
主要结局
Sensitivity of Endoscopic Ultrasound-guided (EUS-guided) Puncture
时间窗: 12 months
The performance of EUS-guided biopsy has been evaluated in terms of sensitivity. EUS-guided was performed after detection of lymph nodes with positron emission tomography (PET). In most cases, only one lymph node is taken and performance analysis will be done by patient and not by injury. PET, the reference technique (gold standard), is followed for 12 months. Sensitivity is the rate of subjects with a diagnosis of malignancy (excluding the results atypical / suspicious or non-contributory) according the results of EUS among all subjects with a neoplastic disease by the gold reference. To sum up , the sensitivity corresponds to the rate of patients detected as "malignant" with the new technique (EUS-guided), among the patients detected as "malignant" at the reference PET examination (12 months assessment).
次要结局
- Negative Predictive Value(12 months)
- Matching Between Therapeutic Strategies RCP1/RCP2(12 months)
- Clinical Utility (Avoid More Invasive Procedure)(12 months)