Determination of the "Tissue Transit Time" (TTT)

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

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

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency, Acute
• Intervention / Treatment: Diagnostic test: Tissue Transit Time

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 Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• Germany
  • Augsburg, Germany, 86156
    • Kinderchirurgische Klinik
  • Bremen, Germany, 28205
    • Klinik für Kinderchirurgie und Kinderurologie
  • Dortmund, Germany, 44137
    • Klinik für Kinderchirurgie und Kinderurologie
  • Karlsruhe, Germany, 76133
    • Kinderchirurgische Klinik
  • Mannheim, Germany, 68167
    • Zentrum für Kinder- und Jugendurologie
  • Marburg, Germany, 35043
    • Klinik für Kinderchirurgie
  • Nürnberg, Germany, 90419
    • Cnopf'sche Kinderklinik
  • Tübingen, Germany, 72076
    • Klinik für Kinder- und Jugendmedzin
• Switzerland
  • Luzern, Switzerland, 6000
    • Kinderchiurgische Klinik, Luzerner Kantonsspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Term born infants <= 3 months of age with a unilateral, insolated hydronephrosis >= grade III (SFU)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and Specificity	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	3 to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examination of ultrasound findings	Relationship between ultrasound findings and the development of the differential renal function	3 to 6 months
Examination of renal drainage	Relationship between initial quality of renal drainage and the development of the differential renal function	3 to 6 months
Examination of initial differential renal function	Relationship between initial differential renal function and the development of the differential renal function	3 to 6 months

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Tobias Luithle, MD, Universtiätsklinikum Tübingen

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 23, 2017
• Primary Completion (ACTUAL): June 30, 2021
• Study Completion (ACTUAL): November 24, 2021

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (ACTUAL): October 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Tissue Transit Time
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: TTT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No