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Conditional Imaging Prescription Strategy for Exploration of Acute Uncomplicated Renal Colic (IMAGENCO)

Primary Purpose

Acute Renal Colic, Nephrolithiasis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Diagnostic imaging modalities for suspected renal colic
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Renal Colic focused on measuring Nephrolithiasis, Ureteral stone, Acute renal colic, Ultrasonography, Computed tomography, Diagnosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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

Exclusion criteria:

  • 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

Sites / Locations

  • Departement of Medical Imaging

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with suspected acute uncomplicated renal colic

Arm Description

Diagnostic imaging

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Radiation exposure dose according to the different imaging strategies tested
The reference strategy will be systematic unenhanced CT.
Diagnostic performances of the tested conditional strategies for the diagnosis of ureteral stone in patients with urethral stone who benefited from urologic management
Diagnostic performances of the tested conditional strategies for alternative diagnosis

Full Information

First Posted
August 19, 2016
Last Updated
October 22, 2019
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02878148
Brief Title
Conditional Imaging Prescription Strategy for Exploration of Acute Uncomplicated Renal Colic
Acronym
IMAGENCO
Official Title
Conditional Imaging Prescription Strategy as an Alternative to Systematic Unenhanced Computed Tomography for Exploration of Acute Uncomplicated Renal Colic With Lower Radiation Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 17, 2016 (Actual)
Primary Completion Date
January 19, 2018 (Actual)
Study Completion Date
February 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Plain abdominal Xray, Ultrasonography and unenhanced CT of the abdomen and pelvis will be performed at the time of admission to the imaging department, within 2 days from ED visit and within a 1 hour delay from each other. Ultrasonography will be interpretated in combination to plain abdominal Xray, and independently from unenhanced CT, by two experienced radiologists blinded to the results of each other.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Renal Colic, Nephrolithiasis
Keywords
Nephrolithiasis, Ureteral stone, Acute renal colic, Ultrasonography, Computed tomography, Diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with suspected acute uncomplicated renal colic
Arm Type
Experimental
Arm Description
Diagnostic imaging
Intervention Type
Device
Intervention Name(s)
Diagnostic imaging modalities for suspected renal colic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diagnostic performances (sensitivity,specificity, calculated according to the tested conditional strategies imaging modality)
Description
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)
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Radiation exposure dose according to the different imaging strategies tested
Description
The reference strategy will be systematic unenhanced CT.
Time Frame
Baseline
Title
Diagnostic performances of the tested conditional strategies for the diagnosis of ureteral stone in patients with urethral stone who benefited from urologic management
Time Frame
Baseline
Title
Diagnostic performances of the tested conditional strategies for alternative diagnosis
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Adult patient Patient admitted to the Emergency department with suspected acute uncomplicated renal colic Exclusion criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire FAGET, MD
Organizational Affiliation
Departement of Medical Imaging - Montpellier University Hospital LAPEYRONIE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of Medical Imaging
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Conditional Imaging Prescription Strategy for Exploration of Acute Uncomplicated Renal Colic

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