Ultrasonic vs. Fluoroscopic Guided PNL in Pediatric Renal Stones

July 26, 2021 updated by: Ayman Asem Elqady, Assiut University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 14 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: ultrasound guided group

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

Intervention: percutaneous nephrolithotomy.
Procedure: Percutaneous nephrolithotomy
Endoscopic kidney stone extraction technique.
Other Names:
  • percutaneous nephrolithotripsy (PNL)
ACTIVE_COMPARATOR: fluoroscopy guided group

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

Intervention: percutaneous nephrolithotomy.
Procedure: Percutaneous nephrolithotomy
Endoscopic kidney stone extraction technique.
Other Names:
  • percutaneous nephrolithotripsy (PNL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone free rate.
Time Frame: Day one post operative.
Stone free rate (less than 4 mm residual is considered free).
Day one post operative.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The need for blood transfusion.
Time Frame: within 24 hours of the procedure.
Amount of transfused blood (if any) in milliliters.
within 24 hours of the procedure.
Surrounding organ injury.
Time Frame: within first 24 hours post operative.
Any injured surrounding organ e.g. liver, spleen or lung will be recorded with the degree of injury.
within first 24 hours post operative.
Radiation exposure.
Time Frame: within one hour during the procedure.
Amount of radiation exposure (during fluoroscopy guided PNL) in millisievert (mSv).
within one hour during the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Ahmed Elderwy, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 20, 2018

Primary Completion (ANTICIPATED)

March 1, 2022

Study Completion (ANTICIPATED)

May 1, 2022

Study Registration Dates

First Submitted

July 23, 2017

First Submitted That Met QC Criteria

August 11, 2017

First Posted (ACTUAL)

August 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB000087618

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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