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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02208518
Enrollment
45
Registered
2014-08-05
Start date
2013-10-31
Completion date
2013-11-30
Last updated
2014-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Pancreatic Tissue

Keywords

Endoscopic Ultrasound elastography, Quantitative elastography, Qualitative elastography, Endoscopic Ultrasound, Elastography

Brief 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.

Interventions

PROCEDUREendoscopy ultrasound elastography

During 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

Sponsors

Instituto Ecuatoriano de Enfermedades Digestivas
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* Endoscopic Ultrasound for evaluate submucosal tumors

Exclusion criteria

* age\<18 or \> 55; pregnancy * history of: pancreatic disease * choledocolithiasis * symptoms of maldigestion * alcohol abuse * increased serum levels of pancreatic enzymes * smokers * Endoscopic Ultrasound with signs of chronic pancreatitis (Rosemont classification)

Design outcomes

Primary

MeasureTime frameDescription
Quantitative Strain Ratio and qualitative Color endoscopy ultrasound elastographytwo monthsThe quantitative Strain Ratio and qualitative Color endoscopy ultrasound elastography was measured in the normal body of the pancreas taking in consideration the curve of the compression rate probe high: +0.4 , middle: 0: less than +0.4 and more than -0.4 \[around baseline=0\], and low: -0.4 in the largest and smaller region of interest diameters. Analysis for qualitative color 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).

Other

MeasureTime frameDescription
Qualitative elastography8 weeksAnalysis for qualitative elastography was obtained by the predominant color of the pancreatic area studied.
Highest compression rate of the probe4 weeksthe curve of the Highest compression rate of the probe: +0.4 , in the largest and smaller region of interest diameters
Middle compression rate of the probe4 weeksthe curve of the Middle compression rate of the probe: 0: less than +0.4 and more than -0.4 \[around baseline=0\], in the largest and smaller region of interest diameters.
Lower compression rate of the probe4 weeksthe curve of the Lower compression rate of the probe: -0.4 in the largest and smaller region of interest diameters

Countries

Ecuador

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026