NCT02929160

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 11, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

3 years

First QC Date

October 7, 2016

Last Update Submit

September 24, 2022

Conditions

Ureteric CalculusSepsisHydronephrosis

Outcome Measures

Primary Outcomes (1)

  • Time to normalisation of white cell count and/or temperature

    Within 1 week

Secondary Outcomes (1)

  • Length of hospital stay

    Within 1 week

Study Arms (2)

PCN

EXPERIMENTAL

Percutaneous nephrostomy

Procedure: Percutaneous nephrostomy

JJ Stent

EXPERIMENTAL

Retrograde ureteric JJ stent

Procedure: Retrograde ureteric JJ stent

Interventions

Percutaneous nephrostomyPROCEDURE

Percutaneous nephrostomy tube insertion under radiological guidance

PCN
Retrograde ureteric JJ stentPROCEDURE

Retrograde ureteric JJ stent insertion using cystoscopy

JJ Stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Adelaide and Meath Hospital, incorporating The National Children's Hospital

Tallaght, Dublin, Ireland

Location

St. James's Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

UreterolithiasisSepsisHydronephrosis

Interventions

Nephrostomy, Percutaneous

Condition Hierarchy (Ancestors)

Ureteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsKidney Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, UrologicalDiagnostic Techniques and ProceduresDiagnosisOstomySurgical Procedures, OperativeNephrotomyUrologic Surgical ProceduresUrogenital Surgical ProceduresUrinary Diversion
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Urologist

Study Record Dates

First Submitted

October 7, 2016

First Posted

October 11, 2016

Study Start

January 1, 2017

Primary Completion

December 31, 2019

Study Completion

January 1, 2020

Last Updated

September 27, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

IE(2)