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

University Hospital Center (CHU)

Status: Completed

Conditions: Acute Renal Colic; Nephrolithiasis

Treatments: Device: Diagnostic imaging modalities for suspected renal colic

Study type: Interventional

Funder types: Other

Identifiers

NCT02878148

2015-A01981-48 (Registry Identifier)

9656

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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220 participants in 1 patient group

Patients with suspected acute uncomplicated renal colic

Experimental group

Description:

Diagnostic imaging

Treatment:

Device: Diagnostic imaging modalities for suspected renal colic