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

Conditional Imaging Prescription Strategy as an Alternative to Systematic Unenhanced Computed Tomography for Exploration of Acute Uncomplicated Renal Colic With Lower Radiation Exposure

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.

Study Overview

• Status: Completed
• Conditions: Nephrolithiasis; Acute Renal Colic
• Intervention / Treatment: Device: Diagnostic imaging modalities for suspected renal colic

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.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Departement of Medical Imaging

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Patients with suspected acute uncomplicated renal colic; Diagnostic imaging

Device: Diagnostic imaging modalities for suspected renal colic; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation exposure dose according to the different imaging strategies tested	The reference strategy will be systematic unenhanced CT.	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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Claire FAGET, MD, Departement of Medical Imaging - Montpellier University Hospital LAPEYRONIE

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 17, 2016
• Primary Completion (ACTUAL): January 19, 2018
• Study Completion (ACTUAL): February 22, 2018

Study Registration Dates

• First Submitted: August 19, 2016
• First Submitted That Met QC Criteria: August 19, 2016
• First Posted (ESTIMATE): August 25, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2019
• Last Update Submitted That Met QC Criteria: October 22, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Computed tomography; Diagnosis; Ultrasonography; Nephrolithiasis; Ureteral stone; Acute renal colic
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pain; Neurologic Manifestations; Infant, Newborn, Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Renal Colic; Colic; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: 9656; 2015-A01981-48 (REGISTRY: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED