Quantitative And Qualitative Eus Elastography

Completed

• Conditions: Normal Pancreatic Tissue
• Interventions: Procedure: endoscopy ultrasound elastography; Device: EUS-elastography

• Registration Number: NCT02208518
• Lead Sponsor: Instituto Ecuatoriano de Enfermedades Digestivas

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.

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2014-03-04
• Status Verified: 2014-08
• Study First Submitted QC: 2014-08-04
• Last Update Submitted: 2014-08-04
• Study First Posted: 2014-08-05
• Last Update Posted: 2014-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elastography analysis	endoscopy ultrasound elastography	Consecutive patients undergoing for upper endoscopy ultrasound
Elastography analysis	EUS-elastography	Consecutive patients undergoing for upper endoscopy ultrasound

Primary Outcome Measures

Name	Time	Method
Quantitative Strain Ratio and qualitative Color endoscopy ultrasound elastography	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).

Trial Locations

Locations (1)

Instituto Ecuatoriano de Enfermedades Digestivas; 🇪🇨 Guayaquil, Guayas, Ecuador