Pediatric Kidney DiseaseNCT03250559
Ultrasonic vs. Fluoroscopic Guided PNL in Pediatric Renal Stones
A study testing Percutaneous nephrolithotomy in people with Pediatric Kidney Disease, run by Assiut University at 1 site in Egypt.
Trial summary
Percutaneous Nephrolithotomy (PNL) was accepted as a treatment modality for large renal stones since 1980. Although radiation exposure during PNL is within the safe limits for expert endourologist, the mutagenic hazard is still present especially in pediatric population. Read more about this study
- Who is it for?
- Ages 6 months to 14 years
- Conditions the study is for
- Pediatric Kidney Disease
- What is being tested?
- Percutaneous nephrolithotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2018to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 months to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All kidney stones in pediatric age group and indicated for PNL.
Who cannot join
- Children unfit for the procedure or non indicated for it.
- Parental refusal.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine-Assiut university
Asyut
Mohammad El-Sharkawi, MD, 0020882412245, mohamed.elsharkawy@med.au.edu.eg
Maha Omar, MD, 0020882413660, mahaghanem@aun.edu.eg
About this study
Official title: Ultrasonic Versus Fluoroscopic Guided Percutaneous Nephrolithotripsy in Pediatric Renal Stones: a Prospective Randomized Study
Percutaneous Nephrolithotomy (PNL) was accepted as a treatment modality for large renal stones since 1980. Although radiation exposure during PNL is within the safe limits for expert endourologist, the mutagenic hazard is still present especially in pediatric population. Therefore, employing an alternative imaging technique during PNL would be of added advantage. So, the investigators want to compare the efficacy of ultrasound guided PNL with the conventional (fluoroscopy guided) PNL in pediatric population. If ultrasound guided PNL was as effective as conventional one, this means that many children could be protected from the variable hazards of radiation exposure.
Read the detailed description
The incidence of pediatric urolithiasis varies by geographic area. Most cases of pediatric urolithiasis are associated with anatomic or metabolic abnormalities or urinary tract infection . PNL can be performed safely and effectively in children by experienced surgeons, resulting in a high stone-free rate and lower requirement for ancillary treatment. In adults, PNL is performed under fluoroscopic or ultrasound guidance. In pediatric age group, fluoroscopic guidance was preferred in most of the reported studies. However, fluoroscopy exposes the patient to radiation. The International Commission on Radiological Protection recommends that whole body exposure in adults should be limited to an effective dose of 20 mSv per year over 5 years. In young children, it is particularly important to protect the developing gonads and thyroid gland, as the long-term effects of exposing these organs to radiation are still unclear. In contrast to fluoroscopic guidance, ultrasound guidance does not expose the patient to radiation, it also can provide real-time monitoring during the puncturing procedure. The path and depth of the needle, and the anatomy in and around the kidney, are clearly visible on ultrasound examination
- Conditions
- Pediatric Kidney Disease
- Being tested
- Percutaneous nephrolithotomy
- Keywords
- Stone disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous nephrolithotomyProcedure or surgery
Also called percutaneous nephrolithotripsy (PNL)
Endoscopic kidney stone extraction technique.
| Study group | Role | What they receive |
|---|---|---|
| ultrasound guided group | Active comparator | The group of renal stones that would have percutaneous nephrolithotomy under ultrasound guidance.
Intervention: percutaneous nephrolithotomy. Receives: Procedure: Percutaneous nephrolithotomy |
| fluoroscopy guided group | Active comparator | The group of renal stones that would have percutaneous nephrolithotomy under fluoroscopy guidance.
Intervention: percutaneous nephrolithotomy. Receives: Procedure: Percutaneous nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate.
Stone free rate (less than 4 mm residual is considered free).
Measured: Day one post operative.
Secondary outcomes (3)
The need for blood transfusion.
Amount of transfused blood (if any) in milliliters.
Measured: within 24 hours of the procedure.
Surrounding organ injury.
Any injured surrounding organ e.g. liver, spleen or lung will be recorded with the degree of injury.
Measured: within first 24 hours post operative.
Radiation exposure.
Amount of radiation exposure (during fluoroscopy guided PNL) in millisievert (mSv).
Measured: within one hour during the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start20 Nov 2018
- Primary completionMar 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Asem Elqady, Assiut University
- Investigators
- Ahmed Elderwy, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250559
- Sponsor's protocol ID
- IRB000087618
- Status last verified
- Jul 2021
- First submitted
- 23 Jul 2017
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeng G, Zhao Z, Wan S, Zhong W, Wu W. Comparison of children versus adults undergoing mini-percutaneous nephrolithotomy: large-scale analysis of a single institution. PLoS One. 2013 Jun 24;8(6):e66850. doi: 10.1371/journal.pone.0066850. Print 2013.
PubMed 23826158
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonic Versus Fluoroscopic Guided Percutaneous Nephrolithotripsy in Pediatric Renal Stones: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03250559
- Acronym / sponsor ID
- IRB000087618
- Conditions
- Pediatric Kidney Disease
- Keywords
- Stone disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 15 Aug 2017 (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.
Percutaneous Nephrolithotomy (PNL) was accepted as a treatment modality for large renal stones since 1980. Although radiation exposure during PNL is within the safe limits for expert endourologist, the mutagenic hazard is still present especially in pediatric population. Therefore, employing an alternative imaging technique during PNL would be of added advantage. So, the investigators want to compare the efficacy of ultrasound guided PNL with the conventional (fluoroscopy guided) PNL in pediatric population. If ultrasound guided PNL was as effective as conventional one, this means that many children could be protected from the variable hazards of radiation exposure.
Detailed description
The incidence of pediatric urolithiasis varies by geographic area. Most cases of pediatric urolithiasis are associated with anatomic or metabolic abnormalities or urinary tract infection . PNL can be performed safely and effectively in children by experienced surgeons, resulting in a high stone-free rate and lower requirement for ancillary treatment. In adults, PNL is performed under fluoroscopic or ultrasound guidance. In pediatric age group, fluoroscopic guidance was preferred in most of the reported studies. However, fluoroscopy exposes the patient to radiation. The International Commission on Radiological Protection recommends that whole body exposure in adults should be limited to an effective dose of 20 mSv per year over 5 years. In young children, it is particularly important to protect the developing gonads and thyroid gland, as the long-term effects of exposing these organs to radiation are still unclear. In contrast to fluoroscopic guidance, ultrasound guidance does not expose the patient to radiation, it also can provide real-time monitoring during the puncturing procedure. The path and depth of the needle, and the anatomy in and around the kidney, are clearly visible on ultrasound examination
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound guided group | Active comparator | Procedure: Percutaneous nephrolithotomyThe group of renal stones that would have percutaneous nephrolithotomy under ultrasound guidance. Intervention: percutaneous nephrolithotomy. |
| fluoroscopy guided group | Active comparator | Procedure: Percutaneous nephrolithotomyThe group of renal stones that would have percutaneous nephrolithotomy under fluoroscopy guidance. Intervention: percutaneous nephrolithotomy. |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All kidney stones in pediatric age group and indicated for PNL.
Key exclusion criteria (2 listed)
- Children unfit for the procedure or non indicated for it.
- Parental refusal.
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 |
|---|---|---|
| Percutaneous nephrolithotomyAlso: percutaneous nephrolithotripsy (PNL)Endoscopic kidney stone extraction technique. | Procedure or surgery | fluoroscopy guided group, ultrasound guided group |
Primary outcome
Stone free rate.
Time frame: Day one post operative.
Stone free rate (less than 4 mm residual is considered free).
3 secondary outcomes
The need for blood transfusion.
Time frame: within 24 hours of the procedure.
Surrounding organ injury.
Time frame: within first 24 hours post operative.
Radiation exposure.
Time frame: within one hour during the procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Background: PubMed 23826158Zeng G, Zhao Z, Wan S, Zhong W, Wu W. Comparison of children versus adults undergoing mini-percutaneous nephrolithotomy: large-scale analysis of a single institution. PLoS One. 2013 Jun 24;8(6):e66850. doi: 10.1371/journal.pone.0066850. Print 2013.
- Individual participant dataSharing planned: No
Related trials for Pediatric Kidney Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruiting
Comparative Feasibility and Effectiveness of Medically Tailored Meals Approaches for Pediatric End-Stage Kidney Disease
End Stage Kidney Disease (ESKD)
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
Lupus Nephritis
RecruitingPhase 4
Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance
Febrile Neutropenia
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. This study is not recruiting at the moment.
Ahmed Elderwy, MD study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous nephrolithotomy in people with Pediatric Kidney Disease, run by Assiut 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayman Elqady, master (0020882102113, Dr.uro87@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone free rate. (time frame: Day one post operative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03250559, which also lists 1 linked publication.
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 28 Jul 2021.