NCT02929160

Percutaneous Nephrostomy Versus Stent In Sepsis Trial

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The Adelaide and Meath Hospital, incorporating The National Children's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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: 1. Image-guided percutaneous nephrostomy tube placement 2. 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.

Conditions

• Ureteric Calculus
• Sepsis
• Hydronephrosis

Interventions

Type	Name	Description
PROCEDURE	Percutaneous nephrostomy	Percutaneous nephrostomy tube insertion under radiological guidance
PROCEDURE	Retrograde ureteric JJ stent	Retrograde ureteric JJ stent insertion using cystoscopy

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-12-31
• Completion: 2020-01-01
• First posted: 2016-10-11
• Last updated: 2022-09-27

Locations

2 sites across 1 country: Ireland