CTT on Renogram as an Early Marker of Significant Obstruction in Uretero-pelvic Junction Syndrome (JUMP)
Primary Purpose
Ureteropelvic Junction Obstruction
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ultrasonography
diuretic renography
Sponsored by
About this trial
This is an interventional diagnostic trial for Ureteropelvic Junction Obstruction focused on measuring ureteropelvic junction obstruction, cortical transit time
Eligibility 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)
Sites / Locations
- CHU de BordeauxRecruiting
- CHU de LimogesRecruiting
- CHU de Nantes
- CHU de Rennes
- Centre Hospitalier Universitaire de La RéunionRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open-label
Arm Description
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
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02812212
First Posted
June 17, 2016
Last Updated
September 27, 2022
Sponsor
Centre Hospitalier Universitaire de la Réunion
1. Study Identification
Unique Protocol Identification Number
NCT02812212
Brief Title
CTT on Renogram as an Early Marker of Significant Obstruction in Uretero-pelvic Junction Syndrome
Acronym
JUMP
Official Title
Cortical Transit Time on Diuretic Renogram as an Early Marker of Significant Obstruction in Antenatally Detected Uretero-pelvic Junction Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 28, 2017 (Actual)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
April 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cortical transit time on diuretic renogram as an early marker of significant obstruction in antenatally detected uretero-pelvic junction syndrome
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteropelvic Junction Obstruction
Keywords
ureteropelvic junction obstruction, cortical transit time
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open-label
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
ultrasonography
Intervention Description
bilateral ultrasonography to measure the antero-posterior renal pelvic diameter (APRPD) in both positions.
Intervention Type
Device
Intervention Name(s)
diuretic renography
Intervention Description
diuretic renography to measure the cortical transit time.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
3 months, 6 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
8 Weeks
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucie Auzanneau
Phone
0262359949
Ext
+262
Email
lucie.auzanneau@chu-reunion.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Valérie Fontaine
Email
promotion.drci@chu-reunion.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luke Harper, MD
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucie AUZANNEAU
Email
lucie.auzanneau@chu-reunion.fr
Facility Name
CHU de Limoges
City
Limoges
ZIP/Postal Code
87000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucie AUZANNEAU
First Name & Middle Initial & Last Name & Degree
Laurent FOURCADE, MD
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucie AUZANNEAU
Email
lucie.auzanneau@chu-reunion.fr
First Name & Middle Initial & Last Name & Degree
Marc-David LECLAIR, MD
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35023
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucie AUZANNEAU
First Name & Middle Initial & Last Name & Degree
Alexis ARNAUD, MD
Facility Name
Centre Hospitalier Universitaire de La Réunion
City
Saint-Denis
ZIP/Postal Code
97400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucie Auzanneau
Ext
+262
Email
lucie.auzanneau@chu-reunion.fr
First Name & Middle Initial & Last Name & Degree
Frédérique SAUVAT, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CTT on Renogram as an Early Marker of Significant Obstruction in Uretero-pelvic Junction Syndrome
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