Conditional Imaging Prescription Strategy for Exploration of Acute Uncomplicated Renal Colic

Not Applicable

Completed

• Conditions: Acute Renal Colic; Nephrolithiasis
• Interventions: Device: Diagnostic imaging modalities for suspected renal colic

• Registration Number: NCT02878148
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-08-19
• Study First Posted: 2016-08-25
• Study Start: 2016-10-17
• Primary Completion: 2018-01-19
• Study Completion: 2018-02-22
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-22
• Last Update Posted: 2019-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with suspected acute uncomplicated renal colic	Diagnostic imaging modalities for suspected renal colic	Diagnostic imaging

Primary Outcome Measures

Name	Time	Method
Diagnostic performances (sensitivity,specificity, calculated according to the tested conditional strategies imaging modality)	Baseline	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

Name	Time	Method
Radiation exposure dose according to the different imaging strategies tested	Baseline	The reference strategy will be systematic unenhanced CT.
Diagnostic performances of the tested conditional strategies for alternative diagnosis	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

Trial Locations

Locations (1)

Departement of Medical Imaging; 🇫🇷 Montpellier, France