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

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ClinicalTrials.gov Identifier: NCT02812212
Recruitment Status : Unknown
Verified January 2017 by Centre Hospitalier Universitaire de la Réunion.
Recruitment status was:  Not yet recruiting
First Posted : June 24, 2016
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion

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

Condition or disease Intervention/treatment Phase
Ureteropelvic Junction Obstruction Device: ultrasonography Device: diuretic renography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cortical Transit Time on Diuretic Renogram as an Early Marker of Significant Obstruction in Antenatally Detected Uretero-pelvic Junction Syndrome
Study Start Date : June 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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.




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   up to 8 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812212


Contacts
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Contact: Julie Dutet, PharmD, PhD +33262905282 julie.dutet@chu-reunion.fr
Contact: Valérie Fontaine +33262906283 drci@chu-reunion.fr

Locations
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France
Centre Hospitalier Universitaire de La Réunion
Saint-Denis, France, 97400
Contact: Julie Dutet, PharmD, PhD    0033262 90 52 82    julie.dutet@chu-reunion.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion
Investigators
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Principal Investigator: Luke Harper, MD CHU La Réunion
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Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT02812212    
Other Study ID Numbers: 2015/CHU/11
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire de la Réunion:
ureteropelvic junction obstruction
cortical transit time
Additional relevant MeSH terms:
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Hydronephrosis
Ureteral Obstruction
Multicystic Dysplastic Kidney
Kidney Diseases
Urologic Diseases
Ureteral Diseases
Urogenital Abnormalities
Kidney Diseases, Cystic
Congenital Abnormalities
Diuretics
Natriuretic Agents
Physiological Effects of Drugs