CClinicalTrials.gg
Status unknownNCT04169555ECHOLINEUpdated Nov 20, 2019

"Point of Care" Ultrasound and Renal Colic

An interventional study of Ultrasound and Standard care in Renal Colic, sponsored by Lille Catholic University. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-20.

Sponsored by Lille Catholic University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The management of renal colic in emergency departments follows the recommendations established at the 8th consensus conference of 2008 on the management of renal colic in emergency services. It recommends the control of pain by nonsteroidal anti-inflammatory drugs and analgesics, the implementation of an urinary test strip and the use of emergency imaging for compiled forms and patient with medical specificities.

Currently, two imaging techniques are recommended during an episode of renal colic:

  1. Abdominal x-ray/Ultrasound or non-injected scanner for simple forms to be performed within 24-48h
  2. The non-injected scanner for complicated forms In simple forms, the decision to perform any examination remains at the discretion of the physician but with a tendency to carry out a scanner systematically even in the absence of criteria of severity or complication.

The use of the scanner exposes the patient to large doses of radiation even if it is a low dose scanner.

In recent years, studies have been conducted to determine whether the ultrasound, particularly "point of care" ultrasound performed by an emergency physician could be an alternative in the management of renal colic. Studies show that the sensitivity and specificity of ultrasound is comparable to that of the scanner. It has been found that the performance of an ultrasound by the emergency physician allows the decrease in irradiation and also in costs. In 2014,a study published in the New England Journal of Medicine emphasized that the ultrasound performed by the emergency physician would perform just as well as that performed by the radiologist and would result in a decreased time in the emergency room.

The Korean study, published in 2016 in the Clinical and Experimental Emergency Medicine (CEEM), despite some statistical inconsistencies, shows a significant reduction in the time of care by 74 minutes. In this context, we would like to conduct a single-centre, randomised, controlled, open-label study comparing a group of patients benefiting from point of care ultrasound versus a group of patients not benefiting from it. The goal is to determine whether the early ultrasound performed by the emergency physician by detecting expansions of the pelvicalyceal cavities reduces the time spent in the emergency department.

02

Conditions studied

  • Renal Colic

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Keywords

  • ultrasound
  • renal colic
  • emergency room
  • point of care
03

In context

Colic

148 studies on the registry are indexed under Colic; 21 are open to participants now.

This study's planned enrollment of 70 is below the median of 88 across 122 interventional studies indexed under Colic.

Browse Colic studies →

Lead sponsor

Lille Catholic University is the lead sponsor of 111 studies on the registry; 26 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

Inclusion criteria

  • Adult patients admitted in ER for suspicion of simple renal colic
  • Signed informed consent

Exclusion criteria

Exclusion Criteria:

  • protected adults (tutorship or guardianship)
  • fever ≥ 38.5°C
  • chronic endstage kidney failure (Glomerular filtration rate \< 30%)
  • Solitary kidney
  • Urinary tract catheter or percutaneous nephrectomy
  • Pregnancy
  • traumatic back pain
  • Renal colic diagnosis in the past three months
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Ultrasound

    Procedure: Ultrasound

  • Other
    Standard care

    Other: Standard care

Interventions

  • ProcedureUltrasound

    The emergency physician will perform a "point of care" ultrasound. If signs of expansions of the pelvicalyceal cavities are found, an early CT scan will follow

  • OtherStandard care

    Standard clinical care of patients. In regards of the clinical evolution and of biological results, a CT scan could be performed by the physician.

06

What researchers measure

Primary outcomes

  1. Time between admission and discharge from the emergency room

    Time frame: Day one

Secondary outcomes

  1. Patients satisfaction scale

    5 questions to be answered by the patients rated on 1-10 scales being equivalent to 1 being equivalent to "no, certainly not and 10 being equivalent to "yes, certainly yes ". An overall score of 50 will be calculated to assess patient satisfaction.

    Time frame: An average of 24 hours

  2. Physician satisfaction scale

    5 questions to be answered by the physicians rated on 1-10 scales being equivalent to 1 being equivalent to "no, certainly not and 10 being equivalent to "yes, certainly yes ". An overall score of 50 will be calculated to assess physician satisfaction.

    Time frame: 9 months

  3. Ultrasound diagnostic performance to detect expansions of the pelvicalyceal cavities

    The diagnostic performance of the ultrasound for the detection of dilation of pyelocalicial cavities will be evaluated by sensitivity and specificity. The Gold Standard will be the result of the scanner

    Time frame: 9 months

07

Study locations

1 of 1 sites recruiting
  • GHICL
    Lille, 59000, France
    • Hervé Duga, MD · Contact · duga.herve@ghicl.net · 03 20 87 45 09
    • Hervé Duga, MD · Principal investigator
    Recruiting
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 Nov 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04169555
Lead sponsor
Lille Catholic University
Responsible party
Sponsor
First posted
Nov 20, 2019
Start date
Oct 7, 2019
Primary completion
Jul 2020 (estimated)
Completion
Jul 2020 (estimated)
Last update
Nov 20, 2019

Study contacts

Amélie Lansiaux, MD, PhD
Contact
lansiaux.amelie@ghicl.net
0320225269 ext. 0033
Jean-Jacques Vitagliano
Contact
vitagliano.jean-jacques@ghicl.net
0320225751 ext. 0033
Duga Hervé, MD
principal investigator · GHICL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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