CTT on Renogram as an Early Marker of Significant Obstruction in Uretero-pelvic Junction Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-8
SponsorCentre Hospitalier Universitaire de la Réunion

About this trial

Cortical transit time on diuretic renogram as an early marker of significant obstruction in antenatally detected uretero-pelvic junction syndrome

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

A bilateral UPJO

An ureteral dilatation

An associated contralateral uropathy

A solitary kidney

Trial design

Design model

Single group

Treatments tested in this trial

  • ultrasonography

    Device

    bilateral ultrasonography to measure the antero-posterior renal pelvic diameter (APRPD) in both positions.

  • diuretic renography

    Device

    diuretic renography to measure the cortical transit time.

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: Open-labelExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

risk, during the first year of life, of an increase of 4mm or more in the measure of APRPD by ultrasonography as compared to the baseline measure, according to the presence or not of an abnormal cortical transit ti

During the first year of life, the antero-posterior renal pelvic diameter will be measured by ultrasonography at baseline, then at 3 months, 6 months and 12 months after baseline. Diuretic renography will be performed only at baseline and the cortical transit time will be classified as normal or abnormal. An increase of 4mm or more of APRPD is the threshold chosen in the study to determine the aggravation of hydronephrosis. The occurence of the increase of 4mm or more in the measure of APRPD will be compared with the normality/abnormality of the cortical transit time in order to determine its value as a prognostic marker.

Time frame
3 months, 6 months and 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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