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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03250559
Other study ID # IRB000087618
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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