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

Study Overview
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Brief Summary
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Randomized comparison of patient outcomes following fluoroscopic guided PCNL versus ultrasound-guided PCNL.

Detailed Description
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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.

Official Title
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Randomized Controlled Trial Comparing Surgical Outcomes Following PCNL Under Ultrasound Control and PCNL Under Fluoroscopic Control in the Treatment of Kidney Stones

Conditions
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Kidney Calculi, Urolithiasis, Kidney Stone, Kidney Diseases, Ureteral Calculi

Intervention / Treatment
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* Procedure: PCNL under fluoroscopic control
* Procedure: PCNL under ultrasound control


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PCNL under fluoroscopic control<br> | Procedure: PCNL under fluoroscopic control<br>* Patients receive standard of care treatment for their urolithiasis using standard PCNL under fluoroscopic guidance<br>|
| Active Comparator: PCNL under ultrasound control<br> | Procedure: PCNL under ultrasound control<br>* Patients receive standard of care treatment for their urolithiasis using standard PCNL under US guidance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss as estimated by postoperative decreases in haemoglobin |  | Post-operative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical outcomes | Outcome measures by using the clavien dindo classification system | 6 months | 
| Asses the easiness of accessibility of the targeted stone | Outcome measures by counting numbers of puncture trial | Intraoperatively | 
| The Puncture fluoroscopy screening time | assessed on the monitor of C-Arm. | Intraoperatively |