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

September 27, 2022 updated by: Centre Hospitalier Universitaire de la Réunion

Cortical Transit Time on Diuretic Renogram as an Early Marker of Significant Obstruction in Antenatally Detected Uretero-pelvic Junction Syndrome

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 the kidney, even if it precedes loss of function, remains unsatisfactory and therefore an earlier marker is needed to improve patients' management.

Determining a reliable early predictive marker for future deterioration of renal function in children with UPJO will considerably change current management of these children by avoiding unnecessary surgery for reversible cases and by being able to offer early surgery before renal deterioration for pathological cases. It could also determine which patients need close surveillance and which do not need to be monitored as often.

Two potential markers have been recently described: the cortical transit time (CTT) measured on renogram, which was shown in a recent retrospective study, to be associated with the need or not for surgery, and positional variation in APRPD as measured by sonography, which was also found to have prognostic value in a recently published pilot study. Both criteria are promising but need to be evaluated prospectively in larger population.

The investigators propose to study prospectively the prognostic value of CTT and as a secondary objective, to determine the prognostic value of positional variation in APRPD. The investigators will then be able to compare these two prognostic markers.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France, 33076
      • Limoges, France, 87000
        • Recruiting
        • CHU de Limoges
        • Principal Investigator:
          • Laurent FOURCADE, MD
      • Nantes, France, 44000
      • Rennes, France, 35023
        • Not yet recruiting
        • CHU de Rennes
        • Principal Investigator:
          • Alexis ARNAUD, MD
      • Saint-Denis, France, 97400
        • Recruiting
        • Centre hospitalier universitaire de la Réunion
        • Contact:
        • Principal Investigator:
          • Frédérique SAUVAT, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Infants:

  • 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
  • whose legal representatives have provided a signed free and informed written consent for their infant's participation
  • whose at least one of his legal representative is affiliated to national social security

Exclusion Criteria:

Infants presenting:

  • A bilateral UPJO
  • An ureteral dilatation
  • An associated contralateral uropathy
  • A solitary kidney
  • A renal insufficiency
  • Severe associated disabilities ( ie polymalformation syndromes)
  • A concomitant participation in another trial
  • A contraindication to furosemide (acute renal insufficiency, hepatic encephalopathy, hypovolemia or dehydration, severe hypokalemia, severe hyponatremia)
  • A contraindication to the radionuclide marker (hypersensitivity to the active substance or to excipients)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-label

Device: ultrasonography and diuretic renography Bilateral ultrasonography to measure the antero-posterior renal pelvic diameter (APRPD) in both positions.

Diuretic renography to measure the cortical transit time
Device: ultrasonography
bilateral ultrasonography to measure the antero-posterior renal pelvic diameter (APRPD) in both positions.
Device: diuretic renography
diuretic renography to measure the cortical transit time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Réunion

Investigators

  • Principal Investigator: Luke Harper, MD, CHU Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2017

Primary Completion (Anticipated)

November 1, 2026

Study Completion (Anticipated)

April 1, 2027

Study Registration Dates

First Submitted

June 17, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimate)

June 24, 2016

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/CHU/11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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