Status:
UNKNOWN
Citrate Salts for Stone-free Result After Flexible Ureterorenoscopy for Inferior Calyx Calculi
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Urolithiasis
Calyx; Calculus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 lithot...
Detailed Description
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 clin...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT04021381
Start Date
September 25 2020
End Date
June 1 2022
Last Update
October 20 2021
Active Locations (1)
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1
Department : Exploration fonctionnelles rénales, Centre de la lithiase Hôpital TENON
Paris, France, 75020