Role of Color Doppler Ultrasound in Lymphadenopathy

Role of Color Doppler Ultrasound in Differentiation Between Benign and Malignant Lymphadenopathy

Lymphadenopathy is defined as an abnormality in the size or character of lymph nodes caused by the invasion or propagation of either inflammatory or neoplastic cells into the nodes Accurate lymph node characterization is important for a wide number of clinical situations, including prognosis, prediction, selecting and monitoring treatment, beyond the diagnosis itself (cancer, lymphoma, or inflammatory nodes)

Study Overview

• Status: Unknown
• Conditions: Lymph Node Disease
• Intervention / Treatment: Device: Colour Doppler

Detailed Description

Various ultrasound criteria that can help in differentiation of benign and malignant lymph nodes have been well described in literature. On Gray scale ultrasound imaging, the benign enlarged lymph nodes are hypoechoic, oval shaped with smooth border and echogenic hilum. On the other hand, the malignant lymph nodes are round with short to long axis ratio >0.5 and show loss of echogenic hilum, while the Color and Power Doppler features documented for the diagnosis of malignant lymph nodes are peripheral and mixed vascularity, with resistive index (RI) more than 0.8, and pulsatility index (PI) more than 1.5 Although Color Doppler ultrasound improves diagnostic accuracy and plays an important adjuvant role to Gray scale ultrasound in differentiating benign from malignant lymph nodes as it adds to the diagnostic confidence of predicting malignancy in enlarged lymph nodes, and also is useful if Gray scale ultrasound findings are equivocal. However, it can neither replace histopathology nor can eliminate the need for biopsy

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• clinically enlarged lymph nodes

Exclusion Criteria:

• previous medical treatment or radiotherapy
• previous biopsy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; patients with lymphadenopathy	Device: Colour Doppler; evaluation of lymph nodes by Doppler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of patients with benign lymphadenopathy	comparison with the biopsy result	one year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): November 30, 2018

Study Record Updates

• Last Update Posted (Actual): November 30, 2018
• Last Update Submitted That Met QC Criteria: November 29, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphadenopathy
• Other Study ID Numbers: Color Doppler Ultrasound

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No