Clinical Outcomes of Percutaneous Nephrolithotomy Following Retrograde Percutaneous Nephrostomy Access Using Novel Device in Comparison to Antegrade Access

Study Overview
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Brief Summary
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The purpose of this study is to compare relevant clinical outcomes in patients requiring percutaneous nephrostomy for urolithiasis treatment between those who undergo an antegrade approach versus a retrograde approach and to determine which clinical characteristics predict success of lithotomy with anterograde or retrograde percutaneous nephrostomy approaches.

Official Title
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Clinical Outcomes of Percutaneous Nephrolithotomy Following Retrograde Percutaneous Nephrostomy Access Using Novel Device in Comparison to Antegrade Access

Conditions
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Kidney Stone

Intervention / Treatment
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* Device: retrograde nephrostomy
* Device: antegrade nephrostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Renal pelvis and proximal ureteral stones >10 mm confirmed with non-contrast computed tomography Exclusion Criteria: Suspected pyelonephritis. Prior percutaneous nephrolithotomy procedure in affected kidney. Mid-ureteral or distal ureteral stones. Pregnancy. Anatomical abnormal kidney, including: Horseshoe Ectopic
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (retrograde nephrostomy)<br> | Device: retrograde nephrostomy<br>* this will consist of one visit to a urologist for retrograde nephrostomy placement using a Retroperc device with lithotomy performed in the same visit and follow up at 4 weeks and 6 months.<br>|
| Active Comparator: Control Group ( antegrade nephrostomy)<br> | Device: antegrade nephrostomy<br>* this will consist of two visits, first to the interventional radiologist for antegrade nephrostomy placement followed by another visit to the urologist for lithotomy with follow up at 4 weeks and 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment efficacy as measured by the time taken from diagnosis to nephrostomy access |  | end of procedure (about 4-8 weeks from diagnosis) | 
| Treatment efficacy as measured by total time of access operation. |  | end of procedure( about 90 minutes after start of procedure) | 
| Treatment efficacy as measured by total time of access operation fluoroscopy |  | end of procedure( about 90 minutes after start of procedure) | 
| Treatment efficacy as measured by total time of lithotomy operation |  | end of procedure(about 3 hours after start of procedure) | 
| Treatment efficacy as measured by total time of lithotomy operation fluoroscopy |  | (end of procedure)about 3 hours after start of procedure | 
| Treatment efficacy as measured by length of post-operative hospital stay |  | 24 hours after procedure | 
| Number of patients that are stone free | stone free is defined as <2mm on non-contrast computed tomography | 6-12 weeks after procedure | 
| Number of patients with symptom free survival as defined as lack of flank pain |  | 6-12 weeks after procedure | 
| Number of patients with symptom free survival as defined as lack of presence of urinary or gastrointestinal symptoms, |  | 6-12 weeks after procedure | 
| Number of patients with symptom free survival as defined as lack of limitations to work |  | 6-12 weeks after procedure | 
| Number of patients with symptom free survival as defined as lack of limitations to social or daily activities. |  | 6-12 weeks after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with nephrostomy access adequate for stone treatment |  | end of procedure( abut 3 hours from start of procedure) | 
| Number of patients with normal vital signs |  | end of procedure( abut 3 hours from start of procedure) | 
| Number of patients with normal laboratory values | laboratory values include complete metabolic panel and urinalysis | 24 hours after procedure | 
| Number of patients with an infection rate which is defined as a positive culture within the study time period |  | 6-12 weeks after procedure | 
| Number of patients that require pain medication (defined as discharge with an opioid prescription). |  | 6-12 weeks after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nephrostomy