Fluoroscopic Guided vs US-guided Percutaneous Nephrolithotripsy for the Treatment of Stone Disease

Astana Medical University

Status

Unknown

Conditions

Kidney Diseases

Kidney Stone

Urolithiasis

Ureteral Calculi

Kidney Calculi

Treatments

Procedure: PCNL under fluoroscopic control

Procedure: PCNL under ultrasound control

Study type

Interventional

Funder types

Other

Identifiers

NCT04606758

Details and patient eligibility

About

Randomized comparison of patient outcomes following fluoroscopic guided PCNL versus ultrasound-guided PCNL.

Full description

This study is a randomized controlled trial that compares the operative outcomes and complications of fluoroscopic guided-percutaneous nephrolithotomy versus ultrasound-guided PCNL for renal stones. This study will be a prospective randomized controlled clinical trial with patients who have already agreed to undergo PCNL. Patients will be randomized at a 1:1 ratio to receive either PCNL under fluoroscopic guidance or PCNL under ultrasound guidance. Patients will be asked to complete pre-operative, and postoperative quality of life questionnaires, and to allow the collection of one additional vial of blood for measurement of factors associated with inflammation.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients planned for PCNL at participating institution
Patients of all ethnic backgrounds
Stone size over 10 mm in diameter and a density over 900 Hounsfield units
Patients with a large calculus in the upper third of the ureter

Exclusion criteria

Pregnancy
infectious disease of the genitals;
conditions that violate the configuration of the kidneys (curvature of the spinal column)
anomalies in the development of the kidneys with impaired configuration and position of the kidneys (horseshoe kidney, bisque kidney, S-shaped kidney, L-shaped kidney, lumbar dystopia, iliac dystopia, pelvic dystopia)
presence of nephrostomy drainage in the target kidney;
urethral stricture or other reason leading to the inability to carry out ureteral catheterization;
other conditions that are contraindications to surgical treatment, such as uncontrolled diabetes mellitus, acute cardiovascular conditions, liver failure, alcoholism, and drug addiction;
patients who are unable to understand the purpose of the study or refuse further follow-up observation and instructions after treatment;
patients with a history of mental illness;
participation in another research that interferes with this research;
acute renal failure;
dissecting aortic aneurysm;
acute hypertensive encephalopathy;
heavy arterial bleeding;
myocardial infarction less than six months before enrollment in the study;
Stroke less than six months before enrollment in the study;
Insufficiency of blood circulation III-IV New York Heart Association class;
Severe rhythm and conduction disturbances;
Increase in the level of liver transaminases by more than three times;