Citrate Salts for Stone-free Result After Flexible Ureterorenoscopy for Inferior Calyx Calculi: a Randomized Placebo Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 262
- 试验地点
- 2
- 主要终点
- Stone-free result
研究概览
简要总结
The prevalence of urolithiasis is around 10 % in the French population. It is thus a major public health issue. When the stone is not spontaneously removed, interventions such as extracorporeal lithotripsy or flexible ureteroscopy (F-URS) are performed. F-URS is usually preferred in renal stones > 7 mm in comparison with lithotripsy, with better results. Efficacy of ureteroscopy is based on the "stone-free rate" (SFR) at 3 months. A SFR index is assessed according to the existence of residual fragments and their size. SFR score 1 (fragment ≤ 1mm) has been poorly studied, and is supposed to occur in 60% of cases. These residual fragments account for the high frequency of recurrence, probably favored by crystals aggregation and growth of these fragments under supersaturated urines.
Indeed, calcium stones risk factors are urine supersaturation and crystal growth inhibitors deficiency. Citrate is the major crystal growth inhibitor in human urine. A hypocitraturia is reported in half of the lithiasic population.
Consequently, citrate salts appear as an interesting therapeutic option, in order to slow crystal growth but also to chelate calcium, and consequently to solubilize stones in situ. However, to date, there is no available controlled study after surgical intervention such as flexible ureteroscopy.
The aim of the investigator's study is to evaluate the efficacy of a 3-month potassium and magnesium citrate treatment following ureteroscopy on the elimination of residual fragments (SFR score 1).
详细描述
The screening visit takes place 3 months to 3 days before the baseline visit. Patient will be informed of the study protocol by the surgeon who will perform the flexible ureteroscopy. As usual in clinical practice, a CT scan will be routinely performed. CT-scan interpretation will be centralized and performed blindly.
At the ureteroscopy day (baseline visit: Some sites, according to their usual practice, may admit their patients to hospital the day before the surgery (D-1)), inclusion and exclusion criteria will be checked by the surgeon. A second information on the study protocol will be given and the protocol consent will be signed.
The day of hospital admission, blood and urine will be collected by a nurse in order to define stone risk factors and other comorbidities after informed consent of the patients. Then patients will undergo ureteroscopy.
Stone fragments will be sent for analysis to the stone centre Laboratory (Tenon Hospital, Paris) with images of the stones during surgery (morphoconstitutional analysis).
Patients will be randomized for treatment within 7 days following F-URS, and after verification of randomization criteria. If the randomisation criteria are not completed, the patient will end its participation to the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 old
- •Efficient contraceptive method in women of childbearing age
- •At least one renal urolithiasis 10 ≤ size ≤ 20 mm
- •No recent ureterorenoscopy (< 6 months)
- •Planned flexible ureterorenoscopy procedure with holmium-laser dusting
- •CT-scan performed within 3 months before surgery
- •Affiliation to a social security regime
- •Informed consent
排除标准
- •Stone density < 700 UH on pre-operative CT-scan
- •History of infectious renal stones or monogenic lithiasic disease (cystinuria, primary hyperoxaluria)
- •Obstructive urinary tract malformation Cacchi-Ricci disease, Horseshoe kidney
- •Chronic renal failure (eGFR<30 ml/min/1.73m²)
- •Ongoing renal colic (within 7 days)
- •Untreated urinary tract infection (within 7 days)
- •Contraindications to ureterorenoscopy: coagulation disorders, high anesthetic risk
- •Contraindications to potassium and magnesium citrate: known hyperkalemia, known hypermagnesemia, uncontrolled diabetes, acute dehydration
- •Pregnant or breastfeeding women
- •Patient deprived of liberty or under legal protection measure (tutorship or curatorship);
- •Participation in another therapeutic trial
结局指标
主要结局
Stone-free result
时间窗: 3 months
Percentage of stone-free patients (SFR score 0 and 1) between the 2 groups at 3 months after ureteroscopy assessed by non-injected, low irradiation, thin slice CT-scan.
次要结局
- SFR score 2, 3 and 4(3 months)
- To evaluate the Safety of potassium and magnesium citrate: Percentage of patients with at least one adverse event throughout the study(3 months)
- Urine supersaturation index(3 months)
- To evaluate the compliance of potassium and magnesium citrate as assessed by citraturia(3 months)
- To evaluate the compliance of potassium and magnesium citrate as assessed by urinary pH(3 months)