Clinical trial NCT05095831: EUS Shear Wave for Solid Pancreatic Lesions.
Official title: Endoscopic Ultrasound Shear Wave for Neoplasia and Inflammation Assessment Among Solid Pancreas Lesions: a Case-control Observational Trial.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreas Neoplasm
Pancreatitis
Pancreatitis, Acute
Pancreatitis, Chronic
Pancreatitis, Autoimmune
Keywords: Pancreatic Neoplasms
Carcinoma, Pancreatic Ductal
Pancreatic Intraductal Neoplasms
Pancreatitis
Pancreatitis, Chronic
Pancreatitis, Alcoholic
Pancreatitis, Acute Necrotizing
Pancreatitis, Acute Hemorrhagic
Autoimmune Pancreatitis
Lead sponsor: Instituto Ecuatoriano de Enfermedades Digestivas
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with solid pancreas lesions with an indication of EUS assessment.

Brief summary: 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.

Detailed description: The pancreas is a retroperitoneal organ that can cause inflammatory and neoplastic diseases, significantly impacting the quality of life to survival. Acute pancreatitis is one of the most frequent gastrointestinal causes for hospital admission in industrialized countries. Chronic pancreatitis, although lower in incidence, significantly reduces patients' quality of life. Pancreas cancer is one of the neoplastic diseases with high mortality worldwide. Those diseases have been associated with significant morbidity, mortality, and hospitalization costs

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). Imaging provides a significant contribution to the diagnosis of pancreatic diseases and severity estimation or staging for inflammatory and neoplastic lesions, respectively. 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 elastography is a novel technique that can measure tissue elasticity by generating shear waves inside the organ using the acoustic radiation force impulse.

EUS Shear wave velocities of healthy parenchyma and solid pancreas lesions as acute, chronic, autoimmune pancreatitis and neoplasia are under described and must be evaluated and contrasted. Therefore, the present study pursues to estimate the diagnostic accuracy of EUS Shear wave for neoplasia assessment among solid pancreas lesions.

Eligibility criteria: Inclusion Criteria:

* Neoplasia group: high suspicion of pancreas neoplasia based on computed tomography and/or nuclear magnetic resonance.
* Inflammatory group: high suspicion of acute or chronic pancreatitis based on computed tomography and/or nuclear magnetic resonance.
* Control group: 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).

Exclusion Criteria:

* Uncontrolled coagulopathy, kidney/liver failure, or any comorbidity with important impact on cardiac risk assessment (NHYA III/IV);
* Impossibility of EUS-guided biopsy (only for neoplasia or inflammatory group);
* Pregnancy or nursing;
* Refuse to participate in the study and/or to sign corresponding informed consent.

Primary outcomes:
measure: SWE/SWD pancreas EUS shear wave
timeFrame: Two months
measure: SR/SH pancreas EUS-elastography
timeFrame: Two months
measure: EUS-biopsied histopathology findings
timeFrame: One month
measure: Clinical condition at one-year follow-up
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Guayaquil
country: Ecuador
facility: Ecuadorian Institute of Digestive Diseases
state: Guayas
Study officials:
affiliation: Ecuadorian Institute of Digestive Diseases
name: Carlos Robles-Medranda, MD FASGE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.