NCT05095831|UnknownDMC
EUS Shear Wave for Solid Pancreatic Lesions.
Endoscopic Ultrasound Shear Wave for Neoplasia and Inflammation Assessment Among Solid Pancreas Lesions: a Case-control Observational Trial.
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Endoscopic Ultrasound Shear Wave for Neoplasia and Inflammation Assessment Among Solid Pancreas Lesions: a Case-control Observational Trial.
Sponsor study identifier
observational
25
1 country
1
Study Start
October 1, 2021
Actual (reported)Primary Completion
January 1, 2022
Actual (reported)Study Completion
April 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The diagnosis of pancreas diseases is based on a combination of clinical signs, symptoms, and laboratory tests, but mainly on imaging techniques such as computed tomography (CT) and magnetic resonance (MR). However, CT/MR have variable sensitivity and specificity, with certain disadvantages. Endoscopic ultrasound with elastography is an important resource with higher diagnostic accuracy in assessing solid pancreas lesions. Shear wave velocities of healthy parenchyma, acute, chronic and autoimmune pancreatitis, neoplastic lesions of the pancreas must be evaluated and compared.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2021
Actual (reported)October 15, 2021
Actual (reported)October 27, 2021
Actual (reported)January 1, 2022
Actual (reported)April 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
SWE/SWD pancreas EUS shear wave
The median of ten SWE/SWD measures will be calculated to represent the final pancreas tissue shear wave measure per case. The higher the median, the more suspicious for neoplasia.
Two months
SR/SH pancreas EUS-elastography
The SR/SH measures will be recorded per case. A SR\>15 kPa and a SH≤45 will be considered as highly suspicious for neoplasia.
Two months
EUS-biopsied histopathology findings
The pathologist will have access to all the clinical data of each patient, including EUS-elastography findings, except shear wave measurements, to determine if the assessed pancreas lesion was neoplasia or inflammatory. In addition, a preliminary diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of pancreas EUS shear wave measurements and pancreas EUS-elastography will be calculated using histopathology results as gold standard.
Patients with high suspicion of solid pancreas neoplasia: carcinoma, intrapapillary mucinous neoplasia (IPMN), neuroendocrine tumor, lymphoma, or intrapancreatic metastasis; based on CT/MR.
Patients with high suspicion of solid inflammatory lesions: acute, chronic, or autoimmune pancreatitis; based on CT/MR.
Patients without a history of any type of solid or hematologic malignancy, hepato-pancreato-biliary disease (including fatty liver and pancreas disease), tobacco/alcohol habits, or morbid obesity with bariatric surgery criteria; who require EUS evaluation (e.g., suspicious of a subepithelial lesion in the context of chronic dyspepsia).
EUS Shear wave elastography (SWE) is a form of ultrasound elastography used in transabdominal ultrasonography. It measures tissue elasticity by generating shear waves inside the organ using the acoustic radiation force impulse (ARFI). The ultrasound machine monitors shear wave propagation and measures the velocity. The shear wave velocity, displayed in kilopascals \[kPa\] or meters per second. Also, the dispersion slope or ultrasound shear wave dispersion (SWD) will be recorded. It is the measure of viscosity \[(m/sec)/kHz\] using SWE. A first endoscopist will perform EUS over pancreas tissue. Without any elastography assessment (strain ratio/histogram) , the endoscopist will take ten shear wave measurements of pancreas tissue elasticity by generating shear waves inside the pancreas using the ARFI.
Adult patients with solid pancreas lesions with an indication of EUS assessment.
Ecuadorian Institute of Digestive Diseases
Guayaquil, Guayas, 090505, Ecuador
Okasha H, Elkholy S, El-Sayed R, Wifi MN, El-Nady M, El-Nabawi W, El-Dayem WA, Radwan MI, Farag A, El-Sherif Y, Al-Gemeie E, Salman A, El-Sherbiny M, El-Mazny A, Mahdy RE. Real time endoscopic ultrasound elastography and strain ratio in the diagnosis of solid pancreatic lesions. World J Gastroenterol. 2017 Aug 28;23(32):5962-5968. doi: 10.3748/wjg.v23.i32.5962.
Bayramoglu Z, Akyol Sari ZN, Koker O, Adaletli I, Eker Omeroglu R. Shear wave elastography evaluation of liver, pancreas, spleen and kidneys in patients with familial mediterranean fever and amyloidosis. Br J Radiol. 2021 Dec;94(1128):20210237. doi: 10.1259/bjr.20210237. Epub 2021 Sep 14.
Carlos Robles-Medranda, MD FASGE
Ecuadorian Institute of Digestive Diseases
First Submitted
October 15, 2021
First Posted
October 27, 2021
Study Start
October 1, 2021
Actual (reported)Primary Completion
January 1, 2022
Actual (reported)Fibro-inflammatory Progression From Acute to Chronic Pancreatitis
One month
Clinical condition at one-year follow-up
A gastroenterologist will follow patients for one year after the procedure. During this follow-up, there will record cases who undergo exploratory or onco-specific surgery (histopathology) and the number of patients who undergo onco-specific treatment (radiotherapy, radiosurgery, chemotherapy, and biological therapy) or clinical management/surveillance. Survival and cause of death will also be recorded when corresponding. This follow-up purposes of determining definitively if the assessed pancreas lesion was neoplasia or inflammatory. A definitive diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of pancreas EUS shear wave measurements and pancreas EUS-elastography will be calculated using a one-year follow-up as the gold standard.
One year
Pancreas EUS-elastography measures the pancreatic tissue stiffness through strain ratio (SR) and strain histogram (SH). A second endoscopist blind to pancreas tissue shear wave findings will perform EUS-elastography with corresponding SR and SH measurements. The SR/SH will be measured and documented. Finally, a pancreas tissue biopsy will be performed. The impossibility of biopsy is an exclusion criterion (except in control patients). Due to ethical purposes, a biopsy will not be performed on patients from the control group.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Platz Batista da Silva N, Engesser M, Hackl C, Brunner S, Hornung M, Schlitt HJ, Evert K, Stroszczynski C, Jung EM. Intraoperative Characterization of Pancreatic Tumors Using Contrast-Enhanced Ultrasound and Shear Wave Elastography for Optimization of Surgical Strategies. J Ultrasound Med. 2021 Aug;40(8):1613-1625. doi: 10.1002/jum.15545. Epub 2020 Oct 30.
Suzuki H, Ishikawa T, Ohno E, Iida T, Uetsuki K, Yashika J, Yamada K, Yoshikawa M, Furukawa K, Nakamura M, Honda T, Ishigami M, Kawashima H, Fujishiro M. An initial trial of quantitative evaluation of autoimmune pancreatitis using shear wave elastography and shear wave dispersion in transabdominal ultrasound. Pancreatology. 2021 Jun;21(4):682-687. doi: 10.1016/j.pan.2021.02.014. Epub 2021 Feb 20.
Study Completion
April 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 4, 2022
Record last verified: 2022-01
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