NCT01471002已完成不适用
Prospective Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy
University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Suspicious contrast enhancement and progression in size of the cryolesion detected by MRI
研究概览
简要总结
The main objective is to evaluate the oncologic efficacy of percutaneous cryoablation of renal tumors smaller than 4 cm in patients with renal cancer that cannot be offered a partial nephrectomy. The oncologic outcome will be assessed by the presence or absence of residue or recurrence during a follow-up by MRI performed the first 12 months (M1, M3, M6, M12).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patients should have the following characteristics:
- •About 75 years, or
- •Whatever the age:
- •A context of family-type tumor (VHL, hereditary carcinoma, tubulo-papillary ...);
- •or solitary kidney, when the tumor is not easily accessible for nephron-sparing surgery: Malignant centro-hilar or intra-parenchymal;
- •or in a local recurrence (single or multiple) after partial nephrectomy (within a limit of 3 tumors to be treated);
- •or in a subject with impaired renal function and therefore at risk of severe renal insufficiency (risk defined by a creatinine clearance below 30 ml / min by MDRD formula);
- •and who do not present any contra-indication for cryoablation treatment.
- •The tumor(s) should meet the following criteria:
- •Presence of one to three solid tumors of the native renal parenchyma with a largest diameter less than (or equal to) 40 mm, which corresponds to a maximum volume of about 32 cc, as measured by MRI.
- •A preoperative MRI is essential since this technique presents a higher sensitivity. This control will also give more consistency to the evaluation of the radiological semiology at follow-up.
- •And its/their location(s) will be accessible to a percutaneous approach.
- •The search of metastases, including a thoracic CT scan, should be negative.
- •Exclusion Criter ia:
- •- Partial nephrectomy feasible in good technical and oncologic conditions in patients under 75 years and in the absence of family tumors.
- •Contraindication to any form of sedation.
- •Irreversible coagulopathy
- •Tumor> 4cm
- •Contraindication to MRI or gadolinium (proven allergy). NB: Patients with a glomerular filtration rate below 30 ml/min/1, 73 m2 will be injected with a single dose of the macrocyclic gadolinium with the highest thermodynamic stability (Dotarem or Prohance), given the united recommendations of AFSSAPS and EMA (European Medicines Agency) [45]. On the contrary, the linear molecules of gadolinium, due to their lower stability, will be contra-indicated because of the risk of systemic nephrogenic fibrosis (FNS).
- •Recurrence on the same location after a procedure performed out of the thermoablation protocol.
- •Biopsy proven benign tumor
- •Predominantly cystic tumor, defined by a necrotic content constituting over one third of tumor volume
- •Presence of endo-venous extension, of proven secondary extensions, visceral or in the lymph nodes (especially lung). In this regard, a thoracic CT scan will be routinely required before treatment, according to the recommendations of urological societies.
- •Psychiatric disorders and adults under guardianship
- •Pregnancy or breastfeeding
- •Minor patients
- •Legal safeguard
- •Participation in another clinical trial
排除标准
- 未提供
结局指标
主要结局
Suspicious contrast enhancement and progression in size of the cryolesion detected by MRI
时间窗: 1 year
The success of cryoablation will be declared if the control at 1 year shows no suspicious contrast enhancement (the suspicious character is defined by significant contrast uptake (\>15%) and heterogeneous or nodular or crescent-shape contrast enhancement) and if the cryolesion is not progressing in size compared to early post-ablation control (M1).
次要结局
未报告次要终点
研究者
研究点 (2)
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