NCT02878148

Brief Summary

Prospective single centre study aiming at validating a conditional imaging strategy for diagnosis of suspected kidney stone. Consecutive Emergency department patients referred to the medical imaging department for exploration of a suspected acute uncomplicated renal colic will undergo the following interventions : systematic plain abdominal Xray, systematic ultrasonography and systematic unenhanced CT (with a reduced dose scan), in addition to clinical examination and assessment of body mass index and the Sex, Timing, Origin, Nausea, Erythrocytes (STONE) clinical prediction score for symptomatic stone. Patients will be followed up at 1 month to record the need for urologic intervention and its type. The performances of different conditional imaging strategy for the diagnosis of suspected renal colic will be assessed retrospectively. The conditional strategies tested will be based on the patient's stone score and BMI and targeted use of combined plain X-ray and ultrasonography and/or unenhanced CT. The reference diagnosis for renal colic will be made according to the finding of a ureteral stone or indirect signs of urolithiasis at unenhanced CT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

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

August 19, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 17, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2018

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

1.3 years

First QC Date

August 19, 2016

Last Update Submit

October 22, 2019

Conditions

Acute Renal ColicNephrolithiasis

Keywords

NephrolithiasisUreteral stoneAcute renal colicUltrasonographyComputed tomographyDiagnosis

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performances (sensitivity,specificity, calculated according to the tested conditional strategies imaging modality)

    Different conditional strategies will be evaluated a posteriori based on the targeted use or not of ultrasonography combined to plain X-ray and/or unenhanced CT, according to the patient's STONE score and BMI. The reference diagnosis for renal colic will be made according to the finding of a ureteral stone or indirect signs of urolithiasis at unenhanced CT (gold standard imaging modality)

    Baseline

Secondary Outcomes (3)

  • Radiation exposure dose according to the different imaging strategies tested

    Baseline

  • Diagnostic performances of the tested conditional strategies for the diagnosis of ureteral stone in patients with urethral stone who benefited from urologic management

    Baseline

  • Diagnostic performances of the tested conditional strategies for alternative diagnosis

    Baseline

Study Arms (1)

Patients with suspected acute uncomplicated renal colic

EXPERIMENTAL

Diagnostic imaging

Device: Diagnostic imaging modalities for suspected renal colic

Interventions

Diagnostic imaging modalities for suspected renal colicDEVICE

All patients with suspected acute uncomplicated renal colic included will undergo ultrasonography in addition to unenhanced CT of pelvis and abdomen and plain X-ray of the abdomen. Imaging examination will be performed according to current guidelines. Ultrasonography study and colour doppler will include the kidney, ureterovesical joint and ureters. Unenhanced CT will be performed using a dedicated low-dose protocol.

Patients with suspected acute uncomplicated renal colic

Eligibility Criteria

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

You may qualify if:

  • Adult patient
  • Patient admitted to the Emergency department with suspected acute uncomplicated renal colic

You may not qualify if:

  • Patient presenting with fever (\>38°C)
  • Patient with persisting pain despite administration of morphinic
  • Patient presenting with anuria
  • Patients with a single kidney and/or history of chronic renal failure
  • Pregnant women or breastfeeding women
  • Patient with a history of renal colic
  • Patients unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Medical Imaging

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Renal ColicNephrolithiasisUreterolithiasisDisease

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesUreteral DiseasesPathologic Processes

Study Officials

  • Claire FAGET, MD

    Departement of Medical Imaging - Montpellier University Hospital LAPEYRONIE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2016

First Posted

August 25, 2016

Study Start

October 17, 2016

Primary Completion

January 19, 2018

Study Completion

February 22, 2018

Last Updated

October 25, 2019

Record last verified: 2019-10

Locations

FR(1)