Clinical Trials Directory

Trials / Completed

CompletedNCT02208518

Quantitative And Qualitative Eus Elastography

Could Quantitative And Qualitative EUS-Elastography Results Be Affected By The Compression Rate And The Diameter Of The Region Of Interest (ROI)?

Status
Completed
Phase
Study type
Observational
Enrollment
45 (actual)
Sponsor
Instituto Ecuatoriano de Enfermedades Digestivas · Academic / Other
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Not accepted

Summary

Endoscopic ultrasonography is considered the most accurate methods for the diagnosis and staging of chronic inflammatory and neoplastic pancreatic diseases. Differential diagnosis of solid pancreatic masses, however, remains a challenge and endoscopic ultrasound-guided fine needle aspiration is necessary. Recently, Endoscopic ultrasound elastography has been introduced as an alternative method to evaluate tissue stiffness of solid pancreatic masses, being an index of tissue elasticity, which may be related to histopathology features (hard tissue = blue = neoplastic and soft tissue = red-yellow-green = non-neoplastic). However, recently publications show different results using elastography. Moreover, a lack of data in Endoscopic ultrasound-elastography exist regarding the compression rate of the probe and the diameter of the region of interest under analysis in previously studies that by physics could affect the tissue elasticity. Based on the hypothesis that elastography could be affected by compression rate of the probe and the diameter of the region of interest analyzed the present study aimed to evaluate the quantitative (strain ratio) and qualitative endoscopic ultrasound-elastography results determined by the compression rate of the probe (measured by the curve of compression in the second generation of elastography) and the diameter of the region of interest in normal pancreatic tissue.

Detailed description

prospective study performed in patients undergoing for upper-endoscopic ultrasound from October 31-to end of November 2013. Endoscopic ultrasound-elastography was performed using linear Pentax-EUS and "Hitachi-Avius". The quantitative-strain ratio and qualitative endoscopic ultrasound-elastography was measured in the body of the pancreas taking in consideration the curve of the compression rate of the probe high: +0.4, middle: 0, low: -0.4 in the largest and smaller region of interest diameters. Analysis for qualitative elastography was obtained by the predominant color of the pancreatic area studied. Pictures where recorded and quantitative strain ratio data were calculated comparing endoscopic ultrasound-elastography of pancreatic tissue with soft tissue (normal mucosal layer: red). Finally, a comparative analysis was performed between the results with the mean normal value for quantitative strain ratio previously published for normal pancreatic tissue, and between the different compression rates of the probe.

Conditions

Interventions

TypeNameDescription
PROCEDUREendoscopy ultrasound elastographyDuring a endoscopy ultrasound (EUS) procedure, in patients with normal pancreas at EUS, elastography was performed using a software already included in Hitachi-Avius machine, pressing the button and obtaining colors and pressure curve given by the software
DEVICEEUS-elastography

Timeline

Start date
2013-10-01
Primary completion
2013-11-01
Completion
2013-11-01
First posted
2014-08-05
Last updated
2014-08-05

Locations

1 site across 1 country: Ecuador

Source: ClinicalTrials.gov record NCT02208518. Inclusion in this directory is not an endorsement.