PyeloplastyNCT07836621
Pyeloplasty in Pediatric Patients With Differential Renal Function Less Than 10%
An observational study of Pyeloplasty and Pediatric Patients, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the postoperative outcomes of pyeloplasty in pediatric patients presenting with ureteropelvic junction obstruction and preoperative differential renal function less than 10%, focusing on: Improvement or stabilization of renal function after surgery. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Pyeloplasty, Pediatric Patients, Differential Renal Function
- What is being tested?
- Pyeloplasty
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This retrospective observational study will be conducted on 26 patients admitted at Urology Department, Tanta University Hospitals in the duration from June 2026 to June 2027.
Who may be able to join
- Age from 1 month to 18 years.
- Diagnosis of primary ureteropelvic junction obstruction.
- Preoperative differential renal function <10% on MAG3 renogram.
- A normal contralateral kidney.
Who cannot join
- Secondary Ureteropelvic Junction Obstruction (UPJO) (postoperative, traumatic, or secondary to other anomalies).
- Solitary functioning kidney.
- Associated vesicoureteral reflux or posterior urethral valves.
- Severe comorbidities affecting renal function.
- Incomplete medical records.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Yossof H Abdul-Qader, MBBCH, 00201005669720, Youssifhamed812@gmail.com
Salah Nagla, MD
About this study
Official title: Outcomes of Pyeloplasty in Pediatric Patients With Differential Renal Function Less Than 10%
This study aims to evaluate the postoperative outcomes of pyeloplasty in pediatric patients presenting with ureteropelvic junction obstruction and preoperative differential renal function less than 10%, focusing on:
- Improvement or stabilization of renal function after surgery.
- Radiological improvement in hydronephrosis.
- Clinical outcomes such as symptom relief and complication rates.
Read the detailed description
Ureteropelvic junction obstruction (UPJO) represents one of the most common causes of hydronephrosis in children.
Historically, kidneys with differential renal function (DRF) below 10% were considered non-salvageable, and nephrectomy was often recommended.
However, recent evidence suggests that pediatric renal units retain significant potential for recovery even when preoperative function is severely reduced.
Numerous studies over the past decade have demonstrated that pyeloplasty in low-functioning kidneys can result in functional improvement, stabilization, and significant symptomatic relief.
- Conditions
- Pyeloplasty, Pediatric Patients, Differential Renal Function
- Being tested
- Pyeloplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyeloplastyProcedure or surgery
Patients will undergo Anderson-Hynes dismembered pyeloplasty for primary ureteropelvic junction obstruction. The procedure was performed through an open, laparoscopic, or mini-incision approach according to the patient's age and the surgeon's clinical judgment. A ureteral stent was inserted when indicated.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with primary ureteropelvic junction obstruction. Receives: Procedure: Pyeloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Differential Renal Function After Pyeloplasty
Differential renal function of the affected kidney will be assessed using MAG-3 diuretic renography. Renal function will be classified as improved when differential renal function increases by at least 5 percentage points, stable when the change is less than 5 percentage points in either direction, and deteriorated when it decreases by at least 5 percentage points.
Measured: 6 months after pyeloplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PyeloplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yossof Hamed Abdul-Wanees Abdul-Qader, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836621
- Sponsor's protocol ID
- 36265MS120/5/26
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Pyeloplasty in Pediatric Patients With Differential Renal Function Less Than 10%
- ClinicalTrials.gov ID
- NCT07836621
- Acronym / sponsor ID
- 36265MS120/5/26
- Conditions
- Pyeloplasty, Pediatric Patients, Differential Renal Function
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the postoperative outcomes of pyeloplasty in pediatric patients presenting with ureteropelvic junction obstruction and preoperative differential renal function less than 10%, focusing on:
- Improvement or stabilization of renal function after surgery.
- Radiological improvement in hydronephrosis.
- Clinical outcomes such as symptom relief and complication rates.
Detailed description
Ureteropelvic junction obstruction (UPJO) represents one of the most common causes of hydronephrosis in children.
Historically, kidneys with differential renal function (DRF) below 10% were considered non-salvageable, and nephrectomy was often recommended.
However, recent evidence suggests that pediatric renal units retain significant potential for recovery even when preoperative function is severely reduced.
Numerous studies over the past decade have demonstrated that pyeloplasty in low-functioning kidneys can result in functional improvement, stabilization, and significant symptomatic relief.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: PyeloplastyPatients with primary ureteropelvic junction obstruction. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This retrospective observational study will be conducted on 26 patients admitted at Urology Department, Tanta University Hospitals in the duration from June 2026 to June 2027.
Key inclusion criteria (4 listed)
- Age from 1 month to 18 years.
- Diagnosis of primary ureteropelvic junction obstruction.
- Preoperative differential renal function <10% on MAG3 renogram.
- A normal contralateral kidney.
Key exclusion criteria (5 listed)
- Secondary Ureteropelvic Junction Obstruction (UPJO) (postoperative, traumatic, or secondary to other anomalies).
- Solitary functioning kidney.
- Associated vesicoureteral reflux or posterior urethral valves.
- Severe comorbidities affecting renal function.
- Incomplete medical records.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PyeloplastyPatients will undergo Anderson-Hynes dismembered pyeloplasty for primary ureteropelvic junction obstruction. The procedure was performed through an open, laparoscopic, or mini-incision approach according to the patient's age and the surgeon's clinical judgment. A ureteral stent was inserted when indicated. | Procedure or surgery | Study group |
Primary outcome
Change in Differential Renal Function After Pyeloplasty
Time frame: 6 months after pyeloplasty
Differential renal function of the affected kidney will be assessed using MAG-3 diuretic renography. Renal function will be classified as improved when differential renal function increases by at least 5 percentage points, stable when the change is less than 5 percentage points in either direction, and deteriorated when it decreases by at least 5 percentage points.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pyeloplasty and Pediatric Patients, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yossof H Abdul-Qader, MBBCH (00201005669720, Youssifhamed812@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Differential Renal Function After Pyeloplasty (time frame: 6 months after pyeloplasty). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.