Percutaneous Nephrostomy Versus Stent In Sepsis Trial

Study Overview
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Brief Summary
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Randomized control trial to compare the efficacy and safety of percutaneous nephrostomy with retrograde ureteric stenting for emergency renal decompression in cases of obstruction and sepsis associated with ureteric calculi.

Detailed Description
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The obstructed kidney in the setting of urosepsis is a urological emergency. Stone manipulation in the setting of active, untreated infection with concomitant urinary tract obstruction can lead to life-threatening sepsis. Therefore, urgent decompression of the collecting system is warranted. There are two options for urgent decompression of an obstructed collecting system: Image-guided percutaneous nephrostomy tube placement Cystoscopic retrograde placement of a ureteric stent This strategy allows drainage of infected urine and penetration of antibiotics to the affected renal unit. Definitive stone manipulation should be delayed until the infection is cleared following an appropriate course of antimicrobial therapy. Both the European Association of Urology (EAU) and the American Urological Association (AUA) provide guidelines for management of an obstructed kidney. Both organisations provide evidence-based statements of the highest recommendation that urgent decompression of the kidney is mandated in the setting of sepsis. However, neither organisation recommend one decompression modality over the other. There is a lack of high quality up-to-date evidence to support a consensus view that one method of decompression is superior to the other. This study aims to determine the most effective method of renal decompression in cases of obstruction and sepsis associated with ureteric calculi.

Official Title
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Optimal Method of Decompression of the Renal Collecting System in Acute Obstruction: a Prospective Randomised Trial

Conditions
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Ureteric Calculus, Sepsis, Hydronephrosis

Intervention / Treatment
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* Procedure: Percutaneous nephrostomy
* Procedure: Retrograde ureteric JJ stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ureteric calculus with proximal hydronephrosis confirmed on CT KUB White cell count >12,000mm3 and/or temperature >38C Exclusion Criteria: Uncorrected coagulopathy Urethral or ureteric stricture disease Urinary diversion Pregnancy

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCN<br>Percutaneous nephrostomy | Procedure: Percutaneous nephrostomy<br>* Percutaneous nephrostomy tube insertion under radiological guidance<br>|
| Experimental: JJ Stent<br>Retrograde ureteric JJ stent | Procedure: Retrograde ureteric JJ stent<br>* Retrograde ureteric JJ stent insertion using cystoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to normalisation of white cell count and/or temperature |  | Within 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | Within 1 week |