Actively Recruiting
Cortical Transit Time on Diuretic Renogram as an Early Marker of Significant Obstruction in Antenatally Detected Uretero-pelvic Junction Syndrome
Led by Centre Hospitalier Universitaire de la Réunion · Updated on 2022-09-29
75
Participants Needed
5
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying ureteropelvic junction obstruction (UPJO) detected before birth, a condition where urine flow from the kidney is blocked, which can cause kidney damage if untreated. This study aims to find early markers of significant obstruction to better decide when surgery is needed. Currently, doctors use diuretic renography and ultrasound, but these methods often detect problems only after kidney damage begins. The study focuses on measuring cortical transit time (CTT) and positional changes in kidney measurements as potential early indicators. Participants will undergo bilateral ultrasonography to measure the antero-posterior renal pelvic diameter (APRPD) in different positions and diuretic renography to measure cortical transit time. These non-invasive imaging tests will be performed at specified intervals to assess kidney function and obstruction severity. The study will compare these two markers to evaluate their ability to predict worsening obstruction. Families of infants aged 4 to 8 weeks with a confirmed unilateral UPJO will be involved. Researchers will monitor changes in APRPD through ultrasound at 3, 6, and 12 months, focusing on whether an increase of 4 mm or more occurs in the first year. The study includes regular imaging and clinical assessments, with the goal to improve early diagnosis and management decisions, reducing unnecessary surgeries and better protecting kidney health.
CONDITIONS
Brief Title
CTT on Renogram as an Early Marker of Significant Obstruction in Uretero-pelvic Junction Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants aged 4 to 8 weeks
- Ureteropelvic junction obstruction detected before birth by ultrasound
- Antero-posterior renal pelvic diameter (APRPD) of 15 mm or more confirmed by ultrasound between days 1 and 15 after birth
- Unilateral ureteropelvic junction obstruction
- Signed informed consent from legal representatives
- At least one legal representative affiliated with national social security
You will not qualify if you...
- Bilateral ureteropelvic junction obstruction
- Ureteral dilatation
- Contralateral uropathy
- Solitary kidney
- Renal insufficiency
- Severe disabilities such as polymalformation syndromes
- Participation in another clinical trial
- Contraindications to furosemide (e.g., acute renal insufficiency, hepatic encephalopathy, hypovolemia, dehydration, severe hypokalemia, severe hyponatremia)
- Contraindications to radionuclide marker (hypersensitivity to active substance or excipients)
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants undergo bilateral ultrasonography to measure the antero-posterior renal pelvic diameter (APRPD) in different positions and diuretic renography to measure cortical transit time as early markers of obstruction.
Visits at 3 months, 6 months, and 12 months
Duration - Up to 12 months
Participants are monitored during the first year of life to assess changes in APRPD and renal function based on diagnostic evaluations.
Follow-up visits at 3, 6, and 12 months post-baseline
Trial Site Locations
Total: 5 locations
1
CHU de Bordeaux
Bordeaux, France, 33076
Actively Recruiting
2
CHU de Limoges
Limoges, France, 87000
Actively Recruiting
3
CHU de Nantes
Nantes, France, 44000
Not Yet Recruiting
4
CHU de Rennes
Rennes, France, 35023
Not Yet Recruiting
5
Centre Hospitalier Universitaire de La Réunion
Saint-Denis, France, 97400
Actively Recruiting
Research Team
L
Lucie Auzanneau
V
Valérie Fontaine
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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