Ultrasonic vs. Fluoroscopic Guided PNL in Pediatric Renal Stones

NCT ID: NCT03250559

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-20
• Study Completion Date: 2022-05-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ultrasound guided group

The group of renal stones that would have percutaneous nephrolithotomy under ultrasound guidance.

Intervention: percutaneous nephrolithotomy.

Group Type: ACTIVE_COMPARATOR

Percutaneous nephrolithotomy

Intervention Type: PROCEDURE

Endoscopic kidney stone extraction technique.

fluoroscopy guided group

The group of renal stones that would have percutaneous nephrolithotomy under fluoroscopy guidance.

Intervention: percutaneous nephrolithotomy.

Group Type: ACTIVE_COMPARATOR

Percutaneous nephrolithotomy

Intervention Type: PROCEDURE

Endoscopic kidney stone extraction technique.

Interventions

Percutaneous nephrolithotomy

Endoscopic kidney stone extraction technique.

Intervention Type: PROCEDURE

Other Intervention Names

percutaneous nephrolithotripsy (PNL)

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ayman Asem Elqady

Principal investigator of urology-Assiut university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Elderwy, MD

Role: STUDY_DIRECTOR

Assiut University

Locations

Faculty of medicine-Assiut university

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ayman Elqady, master

Role: CONTACT

Dr.uro87@gmail.com

0020882102113

Ahmed Elderwy, MD

Role: CONTACT

Ahmad.elderwy@gmail.com

01063544453

Facility Contacts

Mohammad El-Sharkawi, MD

Role: primary

mohamed.elsharkawy@med.au.edu.eg

0020882412245

Maha Omar, MD

Role: backup

mahaghanem@aun.edu.eg

0020882413660

References

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.

Reference Type: BACKGROUND

PMID: 23826158 (View on PubMed)

Other Identifiers

IRB000087618

Identifier Type: -

Identifier Source: org_study_id