Kidney Stone
Conditions
Keywords
nephrostomy, Percutaneous nephrolithotomy (PCNL)
Brief summary
The purpose of this study is to determine the efficacy of RetroPerc® in obtaining renal access for percutaneous nephrolithotomy
Interventions
DEVICEretrograde nephrostomy
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.
DEVICEantegrade nephrostomy
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
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 6-12 weeks after procedure | stone free is defined as \<2mm on non-contrast computed tomography |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 24 hours after procedure | laboratory values include complete metabolic panel and urinalysis |
| 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 | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNadeem N Dhanani, MD,MPH
The University of Texas Health Science Center, Houston
Outcome results
None listed