NCT02464072进行中（未招募）不适用
Randomized Clinical Trial of Subtotal Parathyroidectomy or Total Parathyroidectomy With Immediate Heterotopic Autograft in Chronic Renal Disease Patients Stage V Under Dialysis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
This study evaluates the metabolic and clinical results of two well recognized and accepted surgical techniques in the management of severe hyperparathyroidism in patients under regular dialysis treatment.
详细描述
Prospective randomized trial in the surgical management of severe hyperparathyroidism of chronic kidney disease stage V under dialysis. Patients will be randomized and they will be submitted to subtotal parathyroidectomy or total parathyroidectomy with immediate heterotopic autograft of 45 or 90 fragments of parathyroid tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage V Chronic Kidney Disease patients under regular dialysis treatment with severe hyperparathyroidism requiring parathyroidectomy
排除标准
- •patients refusing to participate in the study (they will receive standard surgery),
- •patients unable to attend regular follow up consultations,
- •patients with a successful kidney transplant at the moment of parathyroidectomy,
- •patients submitted to any previous surgery of the thyroid or parathyroid,
- •patients with chronic kidney disease but not under dialysis
结局指标
主要结局
Survival
时间窗: From the time of the operation until 5 years after intervention or death if it occurs before 5 years of follow up
Five years survival after parathyroidectomy in an intention to treat analysis
次要结局
- Metabolic Outcome 1: Serum Calcium (mg/dL)(1 to 60 months after intervention, Samples are taken according to regular follow up)
- Drug Requirement 4: Calcimimetics (mg/day)(1 to 60 months after intervention, according to the dose prescibed in different periods)
- Metabolic Outcome 2 : Serum Phosphorus (mg/dL)(1 to 60 months after intervention, Samples are taken according to regular follow up)
- Metabolic Outcome 4: Serum Parathormone (pg/mL)(1 to 60 months after intervention, Samples are taken according to regular follow up)
- Metabolic Outcome 3: Serum Alkaline Phosphatase (IU)(1 to 60 months after intervention, Samples are taken according to regular follow up)
- Drug Requirement 3: Sevelamer (mg/day)(1 to 60 months after intervention, according to the dose prescibed in different periods)
- Drug Requirement 2 Calcitriol intake (micrograms/day)(1 to 60 months after intervention, according to the dose prescibed in different periods)
- Clinical Outcome 1: Bone Pain in the VAS(Pre-operative (up to one week before the procedure) until 60 months after intervention)
- Clinical Outcome 3: Quality of Life in the SF-36 Questionnaire(Preoperative (up to three days before the intervention) and until 60 months after intervention)
- Clinical Outcome 4: Additional Operation (Reoperation in Recurrent/Persistent Disease)(1 to 60 months after intervention)
- Drug Requirement 1: Elemental Calcium Intake (g/day)(1 to 60 months after intervention, according to the dose prescibed in different periods.)
- Clinical Outcome 2: Postoperative Skeletal Disease (Fractures/Brown tumor)(1 to 60 months after intervention)
- Morbidity of the surgical procedures(intra-operative to 60 months)
研究者
Sergio Arap
Attending Physcian
University of Sao Paulo General Hospital
研究点 (1)
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