Ureteric CalculusPERSISTNCT02929160
Percutaneous Nephrostomy Versus Stent In Sepsis Trial
A study testing Percutaneous nephrostomy and Retrograde ureteric JJ stent in people with Ureteric Calculus and Sepsis, run by The Adelaide and Meath Hospital, incorporating The National Children's Hospital at 2 sites in Ireland.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteric Calculus, Sepsis, Hydronephrosis
- What is being tested?
- Percutaneous nephrostomy and Retrograde ureteric JJ stent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesIreland
- Study dates
- 1 Jan 2017to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ureteric calculus with proximal hydronephrosis confirmed on CT KUB
- White cell count >12,000mm3 and/or temperature >38C
Who cannot join
- Uncorrected coagulopathy
- Urethral or ureteric stricture disease
- Urinary diversion
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
St. James's Hospital
Dublin
The Adelaide and Meath Hospital, incorporating The National Children's Hospital
Tallaght, Dublin
About this study
Official title: Optimal Method of Decompression of the Renal Collecting System in Acute Obstruction: a Prospective Randomised Trial
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:
- 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.
- Conditions
- Ureteric Calculus, Sepsis, Hydronephrosis
- Being tested
- Percutaneous nephrostomy, Retrograde ureteric JJ stent
- Medical subject headings
- Ureterolithiasis, Sepsis, Hydronephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous nephrostomyProcedure or surgery
Percutaneous nephrostomy tube insertion under radiological guidance
Retrograde ureteric JJ stentProcedure or surgery
Retrograde ureteric JJ stent insertion using cystoscopy
| Study group | Role | What they receive |
|---|---|---|
| PCN | Experimental | Percutaneous nephrostomy Receives: Procedure: Percutaneous nephrostomy |
| JJ Stent | Experimental | Retrograde ureteric JJ stent Receives: Procedure: Retrograde ureteric JJ stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to normalisation of white cell count and/or temperature
Measured: Within 1 week
Secondary outcomes (1)
Length of hospital stay
Measured: Within 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study start1 Jan 2017
- Primary completion31 Dec 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteric CalculusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Adelaide and Meath Hospital, incorporating The National Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rustom P Manecksha, MD, FRCS (Urol.), The Adelaide and Meath Hospital, incorporating The National Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929160
- Sponsor's protocol ID
- AMNCH-GU-2016-1
- Other IDs
- 2016-004022-41, 2016
- Acronym
- PERSIST
- Status last verified
- Sep 2022
- First submitted
- 7 Oct 2016
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Method of Decompression of the Renal Collecting System in Acute Obstruction: a Prospective Randomised Trial
- ClinicalTrials.gov ID
- NCT02929160
- Acronym / sponsor ID
- PERSIST / AMNCH-GU-2016-1
- Conditions
- Ureteric Calculus, Sepsis, Hydronephrosis
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Adelaide and Meath Hospital, incorporating The National Children's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 11 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCN | Experimental | Procedure: Percutaneous nephrostomyPercutaneous nephrostomy |
| JJ Stent | Experimental | Procedure: Retrograde ureteric JJ stentRetrograde ureteric JJ stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ureteric calculus with proximal hydronephrosis confirmed on CT KUB
- White cell count >12,000mm3 and/or temperature >38C
Key exclusion criteria (4 listed)
- Uncorrected coagulopathy
- Urethral or ureteric stricture disease
- Urinary diversion
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous nephrostomyPercutaneous nephrostomy tube insertion under radiological guidance | Procedure or surgery | PCN |
| Retrograde ureteric JJ stentRetrograde ureteric JJ stent insertion using cystoscopy | Procedure or surgery | JJ Stent |
Primary outcome
Time to normalisation of white cell count and/or temperature
Time frame: Within 1 week
1 secondary outcome
Length of hospital stay
Time frame: Within 1 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous nephrostomy and Retrograde ureteric JJ stent in people with Ureteric Calculus and Sepsis, run by The Adelaide and Meath Hospital, incorporating The National Children's Hospital at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to normalisation of white cell count and/or temperature (time frame: Within 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.