Normal Pancreatic Tissue Clinical Trial
Official title:
Could Quantitative And Qualitative EUS-Elastography Results Be Affected By The Compression Rate And The Diameter Of The Region Of Interest (ROI)?
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.
| Status | Completed |
| Enrollment | 45 |
| Est. completion date | November 2013 |
| Est. primary completion date | November 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 55 Years |
| Eligibility |
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) |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Ecuador | Instituto Ecuatoriano de Enfermedades Digestivas | Guayaquil | Guayas |
| Lead Sponsor | Collaborator |
|---|---|
| Instituto Ecuatoriano de Enfermedades Digestivas |
Ecuador,
Dawwas MF, Taha H, Leeds JS, Nayar MK, Oppong KW. Diagnostic accuracy of quantitative EUS elastography for discriminating malignant from benign solid pancreatic masses: a prospective, single-center study. Gastrointest Endosc. 2012 Nov;76(5):953-61. doi: 1 — View Citation
Giovannini M, Hookey LC, Bories E, Pesenti C, Monges G, Delpero JR. Endoscopic ultrasound elastography: the first step towards virtual biopsy? Preliminary results in 49 patients. Endoscopy. 2006 Apr;38(4):344-8. Erratum in: Endoscopy. 2007 Mar;39(3):257. — View Citation
Iglesias García JJ, Lariño Noia J, Alvarez Castro A, Cigarrán B, Domínguez Muñoz JE. Second-generation endoscopic ultrasound elastography in the differential diagnosis of solid pancreatic masses. Pancreatic cancer vs. inflammatory mass in chronic pancreat — View Citation
Iglesias-Garcia J, Larino-Noia J, Abdulkader I, Forteza J, Dominguez-Munoz JE. Quantitative endoscopic ultrasound elastography: an accurate method for the differentiation of solid pancreatic masses. Gastroenterology. 2010 Oct;139(4):1172-80. doi: 10.1053/ — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Highest compression rate of the probe | the curve of the Highest compression rate of the probe: +0.4 , in the largest and smaller region of interest diameters | 4 weeks | Yes |
| Other | Middle compression rate of the probe | 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. | 4 weeks | Yes |
| Other | Lower compression rate of the probe | the curve of the Lower compression rate of the probe: -0.4 in the largest and smaller region of interest diameters | 4 weeks | Yes |
| Other | Qualitative elastography | Analysis for qualitative elastography was obtained by the predominant color of the pancreatic area studied. | 8 weeks | Yes |
| Primary | Quantitative Strain Ratio and qualitative Color endoscopy ultrasound elastography | 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). | two months | Yes |