Clinical trial NCT04856020: Role of Gray Scale and Color Doppler Ultrasound in Diagnosis of Pediatric Neck Masses
Official title: Role of Gray Scale and Color Doppler Ultrasound in Diagnosis of Pediatric Neck Masses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric Tumor
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 96
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients with neck masses attending at outpatient clinics at assiut university pediatric hospital.

Brief summary: Our aim is to assess the role of the gray scale and color Doppler ultrasound in diagnosis of the different pediatric neck masses .

Detailed description: Neck masses are a common occurrence in the pediatric population and often represent a diagnostic challenge for the clinician involved . fortunately , the vast majority of these lesions are ultimately proven to be benign in nature (1).

Even though clinical examination and patient's history are the first and indispensable steps in the initial diagnosis, the role of imaging is crucial, not only to determine whether a mass represents a true tumour or not , but also to achieve a more correct diagnosis and determine the extension of the lesion and its relation with the nearby anatomic structures (2).

Ultrasound (US) should serve as the primary initial imaging modality in children for palpable masses and assessment of superficial glandular structures. Because of the smaller neck size and less subcutaneous fat, sonographic penetration and resolution is generally improved as compared with adults (3 ).

Doppler imaging can also elucidate how flow is distributed within a mass may have diagnostic significance and help us in determining the nature of the lesion as well as it is of great importance in assessment of vascular lesions (4)

Though ultrasound is most common method used for evaluation of pediatric neck masses , and CT as well as MRI are used as an additional tool when necessary ( 3 ) , few studies have looked at the sensitivity and specificity of the different imaging modalities of the pediatric neck masses and most studies have investigated the epidemiology of the pediatric neck masses (5) which make histopathological diagnosis still the gold standard in distinguishing the etiology of pediatric neck masses and ruling out malignant disease (6)

Eligibility criteria: Inclusion Criteria:

- Clinical cases who are suspected for and provisionally diagnosed for "neck swelling" in children (below age of 18 years).

Exclusion Criteria:

1. Patients with conditions that may hinder ultrasound examination like subcutaneous emphysema and thick skin scarring.
2. Patients who are unwilling/uncooperative or have not given consent for participation.

Primary outcomes:
measure: Using gray scale ultrasound to determine the consistency of neck masses in children.
timeFrame: baseline
measure: determination of the extension of neck masses in children.
timeFrame: baseline
measure: determination of the definition of neck masses in children,
timeFrame: baseline
measure: using color doppler ultrasound in assessment neck masses in children.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Samy AbdElAziz, PhD
role: STUDY_CHAIR
affiliation: Assiut University
name: Hazem Abo Zeid, PhD
role: STUDY_DIRECTOR
References:
citation: Riva G, Sensini M, Peradotto F, Scolfaro C, Di Rosa G, Tavormina P. Pediatric neck masses: how clinical and radiological features can drive diagnosis. Eur J Pediatr. 2019 Apr;178(4):463-471. doi: 10.1007/s00431-018-3305-9. Epub 2019 Jan 14.
citation: Toma P, Esposito F, Granata C, Paolantonio G, Terranova MC, Lo Re G, Ferrara D, Rollo M, Zeccolini M, Salerno S. Up-to-date imaging review of paediatric soft tissue vascular masses, focusing on sonography. Radiol Med. 2019 Oct;124(10):935-945. doi: 10.1007/s11547-019-01050-8. Epub 2019 Jun 11.
citation: Friedman ER, John SD. Imaging of pediatric neck masses. Radiol Clin North Am. 2011 Jul;49(4):617-32, v. doi: 10.1016/j.rcl.2011.05.005.
citation: Stern JS, Ginat DT, Nicholas JL, Ryan ME. Imaging of pediatric head and neck masses. Otolaryngol Clin North Am. 2015 Feb;48(1):225-46. doi: 10.1016/j.otc.2014.09.015.