Informations générales (source: ClinicalTrials.gov)
Citrate Salts for Stone-free Result After Flexible Ureterorenoscopy for Inferior Calyx Calculi: a Randomized Placebo Controlled Trial (CiRUS)
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
septembre 2020
juin 2022
26 octobre 2024
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bichat | TABIBZADEH Nathalie | 18/04/2025 07:56:39 | Contacter | ||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | TABIBZADEH Nathalie | 18/04/2025 07:56:39 | Contacter | ||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | TABIBZADEH Nathalie | 18/04/2025 07:56:39 | Contacter | ||
| AP-HP - Hôpital Tenon | TABIBZADEH Nathalie | 18/04/2025 07:56:39 | Contacter | ||
| HOPITAL FOCH | LAURENT YONNEAU | 15/05/2025 05:26:25 | Contacter | ||
Critères
Tous
Inclusion Criteria:
- 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
- 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
- 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