Clinical Trial: CTT on Renogram as an Early Marker of Significant Obstruction in Uretero-pelvic Junction Syndrome
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Cortical Transit Time on Diuretic Renogram as an Early Marker of Significant Obstruction in Antenatally Detected Uretero-pelvic Junction Syndrome
Brief Summary: Cortical transit time on diuretic renogram as an early marker of significant obstruction in antenatally detected uretero-pelvic junction syndrome
Detailed Summary:
Antenatal hydronephrosis (ANH) is an uropathy characterized by a dilatation of the renal collecting system. It is the most common abnormality found during prenatal ultrasound examination (1-5% pregnancies). Though the majority of cases are transient or "functional" and ultimately resolve after birth, some cases have a pathological origin of which ureteropelvic junction obstruction (UPJO) is the most common (7-35% cases).
An increased understanding of the natural history of ANH has been accompanied by a change in its management from systematic surgical approach to active surveillance and selective surgery. The main challenge is then to differentiate reversible ANH from pathological UPJO. Pathological obstruction generally results in an impairment of urine flow which, if left untreated, will result in renal damage or abnormal development of the kidney. It is therefore up to the paediatric urologist to determine whether the obstruction is significant before any irreversible damage occurs. However, without reliable prognostic criteria identified to date, controversy still exists regarding the indication and optimal timing for surgical management of UPJO.
Diuretic renography is currently the most widely used diagnostic modality to evaluate renal function and obstruction. It confirms significant obstruction when it demonstrates alteration of renal function, but having to wait for significant and potentially irreversible loss of function to be able to confirm surgical indication is unsatisfactory.
For many authors increase in hydronephrosis, defined as an increase in the dilatation of antero-posterior renal pelvic diameter (APRPD), is a marker of significant obstruction. But again, having to wait for an increase in hydronephrosis, which is by definition deterioration of
Sponsor: Centre Hospitalier Universitaire de la Réunion
Current Primary Outcome: 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 [ Time Frame: 3 months, 6 months and 12 months ]
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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Centre Hospitalier Universitaire de la Réunion
Dates:
Date Received: June 17, 2016
Date Started: June 2017
Date Completion: June 2020
Last Updated: January 17, 2017
Last Verified: January 2017
