Instituto Ecuatoriano de Enfermedades Digestivas
Guayaquil, Guayas, 1301266, Ecuador
Completed
NCT Number: NCT02208518
Quantitative And Qualitative Eus Elastography
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.
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
endoscopy ultrasound elastography
ProcedureDuring 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
EUS-elastography
DevicePrimary outcomes
-
Quantitative Strain Ratio and qualitative Color endoscopy ultrasound elastography
Time frame: two months
The 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 outcomes
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Highest compression rate of the probe
Time frame: 4 weeks
the 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 probe
Time frame: 4 weeks
the 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 probe
Time frame: 4 weeks
the curve of the Lower compression rate of the probe: -0.4 in the largest and smaller region of interest diameters
-
Qualitative elastography
Time frame: 8 weeks
Analysis for qualitative elastography was obtained by the predominant color of the pancreatic area studied.
Sponsors and collaborators
Lead sponsor
Instituto Ecuatoriano de Enfermedades Digestivas
Other
Registry information
Official study title
Could Quantitative And Qualitative EUS-Elastography Results Be Affected By The Compression Rate And The Diameter Of The Region Of Interest (ROI)?
Important dates
- Study start
- 2013
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Aug 5, 2014
- Registry last updated
- Aug 5, 2014
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.