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Completed

NCT Number: NCT02878148

Conditional Imaging Prescription Strategy for Exploration of Acute Uncomplicated Renal Colic

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.

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Key information

Conditions

Acute Renal Colic Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Colic Signs and Symptoms Ureteral Diseases Ureterolithiasis Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departement of Medical Imaging

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic imaging modalities for suspected renal colic

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.

Primary outcomes

  1. Diagnostic performances (sensitivity,specificity, calculated according to the tested conditional strategies imaging modality)

    Time frame: 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 outcomes

  1. Radiation exposure dose according to the different imaging strategies tested

    Time frame: Baseline

    The reference strategy will be systematic unenhanced CT.

  2. 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

  3. Diagnostic performances of the tested conditional strategies for alternative diagnosis

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: IMAGENCO

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 25, 2016
Registry last updated
Oct 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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