Citrate Salts for Stone-free Result After Flexible Ureterorenoscopy for Inferior Calyx Calculi
NCT ID: NCT04021381
Last Updated: 2021-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
262 participants
INTERVENTIONAL
2020-09-25
2022-06-30
Brief Summary
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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).
Detailed Description
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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.
Else, the patient is randomized and treatment for 3 months (placebo or citrate salts, blinded) will be delivered by the investigational site and administration will begin the day following surgery, thus discharge. A 33 cl glass will be provided for the administration of the treatment. Furthermore 24-hour urine collection will be explained and patients will be given the vessel in order to collect urine at M3 visit.
The end of study visit will take place at 3 months +/- 10 days after ureteroscopy visit.
Medical check-up by the urologist in charge, including a CT-scan and blood and urine biological tests under randomized treatment.
Randomized treatment will be stopped the day of this M3 visit. Adverse events (including drug tolerance, urinary symptoms) and date of stent removal if any will be collected. Compliance will be assessed, using a log book.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Potassium and magnesium citrate
Patients are treated with potassium and magnesium citrate
Potassium and magnesium citrate
Patients are treated with potassium and magnesium citrate 5.2 grams daily during 3 months, following flexible ureterorenoscopy for inferior calyx urolithiasis.
Placebo
Patients are treated with placebo
Placebo
Patient are treated with placebo 5.2 grams daily during 3 months, following flexible ureterorenoscopy for inferior calyx urolithiasis.
Interventions
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Potassium and magnesium citrate
Patients are treated with potassium and magnesium citrate 5.2 grams daily during 3 months, following flexible ureterorenoscopy for inferior calyx urolithiasis.
Placebo
Patient are treated with placebo 5.2 grams daily during 3 months, following flexible ureterorenoscopy for inferior calyx urolithiasis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Nathalie TABIBZADEH, MD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Department : Exploration fonctionnelles rénales, Centre de la lithiase Hôpital TENON
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018-A03500-55
Identifier Type: OTHER
Identifier Source: secondary_id
P170933J
Identifier Type: -
Identifier Source: org_study_id