At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Internal Ureteral Stent Versus Percutaneous Nephrostomy Tube in Management of Acutely Obstructed Infected Kidney in the Presence Upper Urinary Tract Stones: A Prospective, Randomized Study
In Brief
A clinical study evaluating Ureteral stent for Management of Obstructed Infected Kidney. Completed, enrolled 2 participants across 1 site.
Detailed Summary
Non-malignant causes of ureter obstruction can be intrinsic such as stone disease, ureter stricture or congenital ureteropelvic junction obstruction, or extrinsic such as idiopathic retro peritoneal fibrosis. Nearly all clinicians agree that obstructing stones, with a concern for sepsis require immediate decompression of the urinary system. Though large epidemiologic studies of the management of obstructed infected nephrolithiasis demonstrate higher rates of sepsis and mortality associated with PCN placement relative to ureteral stenting, the observational nature of the analysis highlights the need for prospective analyses of PCN vs stenting for obstructive nephrolithiasis. Despite this obvious need, there are few studies comparing the efficacy of ureteral stenting vs PCN in the setting of obstructive urolithiasis. The choice between PCN and stenting is often made by the urologist at initial presentation and can be influenced by factors including disease severity, stone size, location of stone, eventual modality of definitive stone management, or even availability of in-house interventional radiology services. Retrospective studies reveal that both procedures have high success rates. In the setting of unsuccessful stenting, PCN is often successful, but the contrary is not always true. Furthermore, patients are often selected for PCN over ureteral stenting in the setting of larger stones and if they are more severely ill. Goldsmith et al studied 130 patients who underwent decompression for obstructing ureteral stone with PCN or stent placement. Although patients who underwent PCN placement had longer hospital stay, other outcomes such as time to definitive stone management, rates of spontaneous stone passage, and initiation of stone metabolic workup were not statistically different. The authors noted that the method of initial decompression correlated with eventual approach selected for definitive stone management. Patients treated with PCN were more likely to undergo percutaneous definitive management, while patients managed with ureteral stenting were more likely to be treatked with a ureteroscopic approach. Two prospective studies comparing PCN vs stent management of obstructing ureteral stones have conflicting outcomes. Mokhmalji et al 6 in 2001 prospectively randomized 40 patients to receive either PCN or stent. Sixteen out of twenty stents were successfully placed while all twenty PCNs were successfully placed initially. All unsuccessful stents were successfully managed by PCN. Their results demonstrated that stent utilization was less successful as compared to PCN and there was a trend for longer antibiotic therapy due to persistent signs of urinary tract infection in patients who underwent stent placement. In contrast, Pearle et al randomized 42 patients to receive PCN vs stents. This study failed to demonstrate one procedure to be more successful than the other. All 21stents and 20 out of 21 PCNs were successfully placed. One failed PCN successfully underwent stent placement. Their results demonstrated an increased incidence of bacterial urinary colonization post-procedure in the PCN group as compared to the stent group, but overall no differences in time to clinical improvement or length of stay were noted.
Study Details
Timeline
Interventions
Patients will be randomized into 2 groups: Group (A): 75 patients with the use of ureteral stent. Group (B): 75 patients with the use of PCN. How the technique will be applied? Technique of ureteral stent insertion: The ureteral stent will be inserted retrograde by using flexible cystoscope. Technique of PCN insertion: Percutaneous nephrostomy will be performed in the angiography suite by a urologist with the patient under local anesthesia. All the patients will be given non-nephrotoxic antibiotics pre-operatively.