Using diuretic renogram to identify significant obstruction in ureteropelvic junction syndrome

Cortical Transit Time on Diuretic Renogram as an Early Marker of Significant Obstruction in Antenatally Detected Uretero-pelvic Junction Syndrome

This study is testing if a special kidney scan can help doctors tell if infants with ureteropelvic junction obstruction need surgery to prevent kidney damage.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 4 Weeks to 8 Weeks
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de la Réunion (Academic / other)
• Locations: 5 sites (Bordeaux and 4 other locations)
• Trial ID: NCT02812212 on ClinicalTrials.gov

What this trial studies

This study evaluates the use of cortical transit time on diuretic renograms as an early marker for significant obstruction in infants diagnosed with ureteropelvic junction obstruction (UPJO) detected antenatally. It aims to differentiate between reversible antenatal hydronephrosis and pathological UPJO, which can lead to renal damage if untreated. The study involves infants aged 4 to 8 weeks who have been diagnosed with UPJO and will undergo ultrasonography and diuretic renography to assess their condition. The goal is to improve the management of UPJO by providing reliable prognostic criteria for surgical intervention.

Who should consider this trial

Good fit: Ideal candidates for this study are infants aged 4 to 8 weeks with antenatally detected unilateral ureteropelvic junction obstruction.

Not a fit: Patients with bilateral UPJO, associated contralateral uropathy, or severe disabilities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more accurate identification of significant UPJO, potentially preventing renal damage in affected infants.

How similar studies have performed: While the use of diuretic renography is common, this specific approach to early identification of significant obstruction in UPJO is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

Infants:

* Aged of 4 to 8 weeks of life
* Presenting an ureteropelvic junction obstruction (UPJO) detected before birth by ultrasound
* Presenting an UPJO, defined by an Antero-Posterior Renal Pelvic Diameter greater or equal to 15 mm, confirmed by ultrasound post-natally between the 1st and 15th day of life
* Presenting a unilateral UPJO
* whose legal representatives have provided a signed free and informed written consent for their infant's participation
* whose at least one of his legal representative is affiliated to national social security

Exclusion Criteria:

Infants presenting:

* A bilateral UPJO
* An ureteral dilatation
* An associated contralateral uropathy
* A solitary kidney
* A renal insufficiency
* Severe associated disabilities ( ie polymalformation syndromes)
* A concomitant participation in another trial
* A contraindication to furosemide (acute renal insufficiency, hepatic encephalopathy, hypovolemia or dehydration, severe hypokalemia, severe hyponatremia)
* A contraindication to the radionuclide marker (hypersensitivity to the active substance or to excipients)

Where this trial is running

Bordeaux and 4 other locations

• CHU de Bordeaux — Bordeaux, France (Recruiting)
• CHU de Limoges — Limoges, France (Recruiting)
• CHU de Nantes — Nantes, France (Not_yet_recruiting)
• CHU de Rennes — Rennes, France (Not_yet_recruiting)
• Centre Hospitalier Universitaire de La Réunion — Saint-Denis, France (Recruiting)

Study contacts

• Principal investigator: Luke Harper, MD — University Hospital, Bordeaux
• Study coordinator: Lucie Auzanneau

Conditions Ureteropelvic Junction Obstruction; ureteropelvic junction obstruction; cortical transit time