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WithdrawnNCT02929160PERSISTUpdated Sep 27, 2022

Percutaneous Nephrostomy Versus Stent In Sepsis Trial

An interventional study of Percutaneous nephrostomy and Retrograde ureteric JJ stent in Ureteric Calculus, Sepsis and Hydronephrosis, sponsored by The Adelaide and Meath Hospital, incorporating The National Children's Hospital. Withdrawn at 2 sites in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-27.

Sponsored by The Adelaide and Meath Hospital, incorporating The National Children's Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ureteric Calculus
  • Sepsis
  • Hydronephrosis
03

In context

Ureterolithiasis

84 studies on the registry are indexed under Ureterolithiasis; 19 are open to participants now.

Browse Ureterolithiasis studies →

Lead sponsor

The Adelaide and Meath Hospital, incorporating The National Children's Hospital is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ureteric calculus with proximal hydronephrosis confirmed on CT KUB
  • White cell count >12,000mm3 and/or temperature >38C

Exclusion criteria

Exclusion Criteria:

  • Uncorrected coagulopathy
  • Urethral or ureteric stricture disease
  • Urinary diversion
  • Pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    PCN

    Percutaneous nephrostomy

    Procedure: Percutaneous nephrostomy

  • Experimental
    JJ Stent

    Retrograde ureteric JJ stent

    Procedure: Retrograde ureteric JJ stent

Interventions

  • ProcedurePercutaneous nephrostomy

    Percutaneous nephrostomy tube insertion under radiological guidance

  • ProcedureRetrograde ureteric JJ stent

    Retrograde ureteric JJ stent insertion using cystoscopy

06

What researchers measure

Primary outcomes

  1. Time to normalisation of white cell count and/or temperature

    Time frame: Within 1 week

Secondary outcomes

  1. Length of hospital stay

    Time frame: Within 1 week

07

Study locations

2 sites
  • The Adelaide and Meath Hospital, incorporating The National Children's Hospital
    Tallaght, Dublin, Ireland
  • St. James's Hospital
    Dublin, Ireland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02929160
Lead sponsor
The Adelaide and Meath Hospital, incorporating The National Children's Hospital
Responsible party
Rustom P Manecksha, MD, FRCS (Urol.) (Consultant Urologist, The Adelaide and Meath Hospital, incorporating The National Children's Hospital) — Principal investigator
First posted
Oct 11, 2016
Start date
Jan 1, 2017
Primary completion
Dec 31, 2019
Completion
Jan 2020
Last update
Sep 27, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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