Feasibility of Radiation-Free Percutaneus Nephrolithotomy for Kidney Stones

NCT06922006 | Active Not Recruiting

• 1 other identifier: IRB#180946
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to investigate the feasibility of ultrasound-guided percutaneus nephrolithotomy in patients with kidney stones. The main question's it aims to answer are: Does the use of ultrasound in percutaneus nephrolithotomy affect stone free rates, defined by no stone or stone \<2mm, on follow up visit? Does the use of ultrasound in percutaneus nephrolithotomy affect complication rates, categorized by Clavien system? Researchers will compare ultrasound-guided percutaneus nephrolithotomy to traditional nephrolithotomy using fluoroscopy to see if outcomes differ. Participants will be chosen for any of the above interventions at surgeon's discretion.

Conditions

Kidney Stones

Keywords

PCNL

Outcome Measures

Primary Outcomes (1)

• Stone free rates

  The rate of patients with no stone, or \<2mm stone on follow up visit.

  4-6 weeks after surgery.

Secondary Outcomes (12)

• Complication rates

  From date of surgery to 30 days post surgery.

• ED visits

  From surgery to 30 days after surgery.

• Re-admission rates

  From surgery to 30 days after surgery.

• Required additional procedure after PCNL.

  From surgery to 30 days after surgery.

• End of case residual stone prescense.

  At the end of surgery (In the operating room).

Study Arms (3)

Radiation-free PCNL

Cases that were done using ultrasound as the only imaging modality during the entire procedure.

Procedure: Percutaneus nephrolithotomy (PCNL)

Fluoroscopy-guided PCNL

Traditional PCNL's that were planned and performed with fluoroscopy.

Procedure: Percutaneus nephrolithotomy (PCNL)

Converted from radiation-free to fluoroscopy-guided PCNL

Cases that were planned to be done with ultrasound but that ended up having to use fluoroscopy.

Procedure: Percutaneus nephrolithotomy (PCNL)

Interventions

Percutaneus nephrolithotomy (PCNL) PROCEDURE

Percutaneus nephrolithotomy (PCNL) for removal of large kidney stones

Converted from radiation-free to fluoroscopy-guided PCNL; Fluoroscopy-guided PCNL; Radiation-free PCNL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General population with kidney stones larger than 20mm.

You may qualify if:

• Scheduled percutaneus nephrolithotomy by Dr. Roger Sur between 2022 and 2025 at UCSD Hillcrest.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego, Hillcrest

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Roger L Sur, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 10, 2025
• Study Start: March 26, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

US (1)