Ultrasonic vs. Fluoroscopic Guided PNL in Pediatric Renal Stones

Pediatric Kidney Disease Clinical Trial

Official title:

Ultrasonic Versus Fluoroscopic Guided Percutaneous Nephrolithotripsy in Pediatric Renal Stones: a Prospective Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03250559
• Other study ID #: IRB000087618
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2018
• Est. completion date: May 2022

Study information

• Verified date: July 2021
• Source: Assiut University
• Contact: Ayman Elqady, master
• Phone: 0020882102113
• Email: Dr.uro87[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: May 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 14 Years

Eligibility

Inclusion Criteria:

• All kidney stones in pediatric age group and indicated for PNL.

Exclusion Criteria:

• Children unfit for the procedure or non indicated for it.
• Parental refusal.

Related Conditions & MeSH terms

• Kidney Diseases
• Pediatric Kidney Disease

Intervention

Procedure:
• Percutaneous nephrolithotomy
Endoscopic kidney stone extraction technique.

Locations

Country	Name	City	State
Egypt	Faculty of medicine-Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone free rate.	Stone free rate (less than 4 mm residual is considered free).	Day one post operative.
Secondary	The need for blood transfusion.	Amount of transfused blood (if any) in milliliters.	within 24 hours of the procedure.
Secondary	Surrounding organ injury.	Any injured surrounding organ e.g. liver, spleen or lung will be recorded with the degree of injury.	within first 24 hours post operative.
Secondary	Radiation exposure.	Amount of radiation exposure (during fluoroscopy guided PNL) in millisievert (mSv).	within one hour during the procedure.