Conditional Imaging Prescription Strategy for Exploration of Acute Uncomplicated Renal Colic

NCT ID: NCT02878148

Last Updated: 2019-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-17
• Study Completion Date: 2018-02-22

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.

Conditions

Acute Renal Colic; Nephrolithiasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with suspected acute uncomplicated renal colic

Diagnostic imaging

Group Type: EXPERIMENTAL

Diagnostic imaging modalities for suspected renal colic

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claire FAGET, MD

Role: PRINCIPAL_INVESTIGATOR

Departement of Medical Imaging - Montpellier University Hospital LAPEYRONIE

Locations

Departement of Medical Imaging

Montpellier, , France

Countries

France

Other Identifiers

2015-A01981-48

Identifier Type: REGISTRY

Identifier Source: secondary_id

9656

Identifier Type: -

Identifier Source: org_study_id