Clinical Trial: Clinical Impact of EUS Elastography Mean Strain Histograms (SH) and Contrast Peak-enhancement in Focal Pancreatic Masses and Lymph Nodes
Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational
Official Title: Real-time Semi-quantification of Endoscopic Ultrasound Elastography and Contrast-enhancement Using Strain Histograms (SH) and Contrast-enhancement (CE) for the Differentiation of Focal Pancreatic Mass
Brief Summary: The study protocol is based on a multi-center semi-quantitative approach of EUS elastography data in combination with contrast-enhanced EUS, consisting of measuring SR and SH for focal pancreatic masses and lymph nodes, as well as several parameters of CE-EUS based on time-intensity-curve (TIC) analysis. A number of parameters must be taken into consideration, as the ROIs are still manually selected by the user. The aim of the study is to establish an EUS based diagnostic algorithm in patients with pancreatic masses and lymph nodes, with negative or inconclusive cytopathology after EUS-FNA, based on previously published results and cut-offs of elastography and contrast-enhancement. The proposed algorithm of sequential use of real-time elastography, followed by contrast-enhanced EUS could be a good clinical tool to help select the patients with possible pancreatic adenocarcinoma or malignant lymph nodes, in the setting of patients with negative EUS-FNA results.
Detailed Summary:
1. Background Endoscopic ultrasound (EUS) is a technique with a major clinical impact in digestive diseases, determining a change in the diagnosis and management of more than half of examined patients [1]. Recent advances in EUS-FNA techniques, but also the development of real-time EUS elastography and contrast-enhancement, allowed a better characterization of focal pancreatic masses, with possible implications in the management of patients with negative EUS-FNA and a strong suspicion of malignancy.
1.a Elastography Elastography is a recent ultrasound method used for the reconstruction of tissue elasticity distribution in real-time [2]. The method allows the calculation of the elasticity modulus, consequently showing differences in tissue hardness patterns that are determined by diseases. The main intended use is to differentiate between benign and malignant focal lesions based on the significantly smaller strain of the latter [3]. Second generation elastography introduces strain ratio (SR) and strain histogram (SH) as reproducible parametric measurements that retrieve numerical values in real time, adding quantification possibilities to the technique [4]. Elastography typically estimates the axial strain (along the direction of insonification / compression) by analyzing ultrasonic signals obtained with standard ultrasonographic systems - the RF signals returned from tissue structures before and after slight compression (about 1%) are compared [5]. Tissue elastography can be easily performed with conventional probes, including the linear EUS probes used for the examination of the pancreas and/or lymph nodes. The calculation of tissue elasticity distribution is performed in real-time under freehand compression and the examination results are represented as transparent overlay colour images overimposed on the conventional gray-scale B-mode images [6]. Thus, this method allo
Sponsor: University of Medicine and Pharmacy Craiova
Current Primary Outcome: Strain histogram and contrast enhancement during EUS in pancreatic masses and lymph nodes [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Medicine and Pharmacy Craiova
Dates:
Date Received: May 28, 2015
Date Started: January 2015
Date Completion: January 2017
Last Updated: May 28, 2015
Last Verified: May 2015
