Determination of the "Tissue Transit Time" (TTT)

Completed

• Conditions: Renal Insufficiency, Acute

• Registration Number: NCT03311256
• Lead Sponsor: University Hospital Tuebingen

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

Study Timeline

• Study First Submitted: 2017-10-11
• Study First Submitted QC: 2017-10-11
• Study First Posted: 2017-10-17
• Study Start: 2017-11-23
• Status Verified: 2020-11
• Primary Completion: 2021-06-30
• Study Completion: 2021-11-24
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity	3 to 6 months	Estimation of Sensitivity and Specificity of a delayed tissue transit time as a diagnostic factor concerning worsening of the differential renal function in patients with congenital ureteropelvic junction obstruction

Secondary Outcome Measures

Name	Time	Method
Examination of ultrasound findings	3 to 6 months	Relationship between ultrasound findings and the development of the differential renal function
Examination of renal drainage	3 to 6 months	Relationship between initial quality of renal drainage and the development of the differential renal function
Examination of initial differential renal function	3 to 6 months	Relationship between initial differential renal function and the development of the differential renal function

Trial Locations

Locations (7)

Cnopf'sche Kinderklinik; 🇩🇪 Nürnberg, Germany

Klinik für Kinder- und Jugendmedzin; 🇩🇪 Tübingen, Germany

Klinik für Kinderchirurgie und Kinderurologie; 🇩🇪 Dortmund, Germany

Kinderchirurgische Klinik; 🇩🇪 Karlsruhe, Germany

Zentrum für Kinder- und Jugendurologie; 🇩🇪 Mannheim, Germany

Kinderchiurgische Klinik, Luzerner Kantonsspital; 🇨🇭 Luzern, Switzerland

Klinik für Kinderchirurgie; 🇩🇪 Marburg, Germany