2021-10-01
2022-01-01
2022-04-01
25
NCT05095831
Instituto Ecuatoriano de Enfermedades Digestivas
Instituto Ecuatoriano de Enfermedades Digestivas
OBSERVATIONAL
EUS Shear Wave for Solid Pancreatic Lesions.
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-10-15 | N/A | 2022-01-03 |
2021-10-15 | N/A | 2022-01-04 |
2021-10-27 | N/A | 2022-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Suspicion of solid neoplastic lesion Patients with high suspicion of solid pancreas neoplasia: carcinoma, intrapapillary mucinous neoplasia (IPMN), neuroendocrine tumor, lymphoma, or intrapancreatic metastasis; based on CT/MR. | DIAGNOSTIC_TEST: Pancreas EUS shear wave
DIAGNOSTIC_TEST: Pancreas EUS-elastography and EUS-guided biopsy
|
| : Suspicion of a solid inflammatory lesion Patients with high suspicion of solid inflammatory lesions: acute, chronic, or autoimmune pancreatitis; based on CT/MR. | DIAGNOSTIC_TEST: Pancreas EUS shear wave
DIAGNOSTIC_TEST: Pancreas EUS-elastography and EUS-guided biopsy
|
| : 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 | DIAGNOSTIC_TEST: Pancreas EUS shear wave
DIAGNOSTIC_TEST: Pancreas EUS-elastography and EUS-guided biopsy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | 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 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
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