EUS Shear Wave for Solid Pancreatic Lesions.

January 3, 2022 updated by: Instituto Ecuatoriano de Enfermedades Digestivas

Endoscopic Ultrasound Shear Wave for Neoplasia and Inflammation Assessment Among Solid Pancreas Lesions: a Case-control Observational Trial.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ecuador
    • Guayas
      • Guayaquil, Guayas, Ecuador, 090505
        • Ecuadorian Institute of Digestive Diseases

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with solid pancreas lesions with an indication of EUS assessment.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

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.

Diagnostic test: Pancreas EUS-elastography and EUS-guided biopsy

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.
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

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.

Diagnostic test: Pancreas EUS-elastography and EUS-guided biopsy

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.
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).
Diagnostic test: Pancreas EUS shear wave

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.

Diagnostic test: Pancreas EUS-elastography and EUS-guided biopsy

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SWE/SWD pancreas EUS shear wave
Time Frame: Two months
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
Time Frame: Two months
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
Time Frame: One month
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
Time Frame: One year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Ecuatoriano de Enfermedades Digestivas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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 Major Dates

Study Start (ACTUAL)

October 1, 2021

Primary Completion (ACTUAL)

January 1, 2022

Study Completion (ANTICIPATED)

April 1, 2022

Study Registration Dates

First Submitted

October 15, 2021

First Submitted That Met QC Criteria

October 15, 2021

First Posted (ACTUAL)

October 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 4, 2022

Last Update Submitted That Met QC Criteria

January 3, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IECED-10152021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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