Clinical trial NCT03311256: Determination of the "Tissue Transit Time" (TTT)
Official title: Determination of the "Tissue Transit Time" (TTT) in the MAG3-Tc99 Diuretic Renogram for Risk Stratification of Infants With Ureteropelvic Junction Obstruction - a Multicentric Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Insufficiency, Acute
Keywords: Tissue Transit Time
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 119
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Term born infants \<= 3 months of age with a unilateral, insolated hydronephrosis \>= grade III (SFU)

Brief summary: Determination of Tissue Transit Time (TTT) as a parameter with high prognostic value to predict the functional course of the differential renal function and the development of the differential renal function after pyeloplasty

Detailed description: The ureteropelvic junction obstruction occurs in around 13% of children with antenatally diagnosed hydronephrosis. It remains a controversial topic what prognostic factors may be predictive for deterioration of the differential renal function.

The tissue transit time (TTT) in the 99mTc- MAG3 diuretic renogram seems to be a predictive factor for the deterioration of the differential renal function in these patients. We therefore analyze the tissue transit time in the 99mTc- MAG3 diuretic renogram in a prospective multicenter observational study to determine it as a prognostic and diagnostic factor. Aim of the study is to differentiate which children could be treated conservatively and which will benefit from operative pyeloplasty

Eligibility criteria: Inclusion Criteria:

* unilateral, isolated hydronephrosis \>= grade III (SFU)
* age \<= 3 months

Exclusion Criteria:

* associated malformation of the urogenital tract
* global kidney insufficiency proven by creatinine examination
* prematurity
* no informed consent

Primary outcomes:
measure: Sensitivity and Specificity
timeFrame: 3 to 6 months
Secondary outcomes:
measure: Examination of ultrasound findings
timeFrame: 3 to 6 months
measure: Examination of renal drainage
timeFrame: 3 to 6 months
measure: Examination of initial differential renal function
timeFrame: 3 to 6 months
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Kinderchirurgische Klinik
city: Bremen
country: Germany
facility: Klinik für Kinderchirurgie und Kinderurologie
city: Dortmund
country: Germany
facility: Klinik für Kinderchirurgie und Kinderurologie
city: Karlsruhe
country: Germany
facility: Kinderchirurgische Klinik
city: Mannheim
country: Germany
facility: Zentrum für Kinder- und Jugendurologie
city: Marburg
country: Germany
facility: Klinik für Kinderchirurgie
city: Nürnberg
country: Germany
facility: Cnopf'sche Kinderklinik
city: Tübingen
country: Germany
facility: Klinik für Kinder- und Jugendmedzin
city: Luzern
country: Switzerland
facility: Kinderchiurgische Klinik, Luzerner Kantonsspital
Study officials:
affiliation: Universtiätsklinikum Tübingen
name: Tobias Luithle, MD
role: PRINCIPAL_INVESTIGATOR
References: