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Shear Wave ElastographyNCT04964648

Shear Wave Elastography in Diagnosis of Inflammatory and Malignant Pancreatic Diseases

An observational study of Shear Wave Elastography and Pancreatic Diseases, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Only a few studies that have assessed the normal range value for pancreatic stiffness, inflammatory and malignant pancreatic lesions, shear wave velocities of healthy parenchyma, acute and chronic pancreatitis, malignant lesions of the pancreas will be evaluated and compared with other conventional imaging modalities… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Shear Wave Elastography, Pancreatic Diseases
What is being tested?
shear wave elastography
Type of treatment
Medical device
How many people
100 participants
Where
No sites listed yet
Study dates
10 Jul 2021to 10 Jul 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: * Inflammatory and Malignant pancreatic lesions who will be admitted in Al-Rajhi University Liver Hospital, Assiut, Egypt. * control group: Healthy adult subjects who will be evaluated for annual check-up in Al-Rajhi University Liver Hospital, Assiut, Egypt.

Who may be able to join

  • Inflammatory pancreatic lesions (acute or chronic pancreatitis)
  • Malignant pancreatic lesions
  • Healthy adult control

Who cannot join

  • Patient with difficult visualization of the pancreas on B-mode sonography.
  • Patients with acute liver diseases.
  • Obese patient (body mass index >30 kg/m2).

Trial locations and contacts

No sites are listed yet.

Zeinab Ramadan, Assistant lecturer contact

01017800673

z.zedan@aun.edu.eg

Zainab Gaber, Assistant professor contact

01004496692

zainabgaber@yahoo.com

About this study

Official title: The Validity of Shear Wave Elastography in Diagnosis of Inflammatory and Malignant Pancreatic Diseases

Only a few studies that have assessed the normal range value for pancreatic stiffness, inflammatory and malignant pancreatic lesions, shear wave velocities of healthy parenchyma, acute and chronic pancreatitis, malignant lesions of the pancreas will be evaluated and compared with other conventional imaging modalities, and evaluate its role in assessment of severity and prediction of clinical course/ outcome in patients with inflammatory pancreatic diseases.

Read the detailed description

The pancreas is a retroperitoneal organ that has several serious inflammatory and malignant diseases can occur, inflammatory diseases include acute and chronic pancreatitis (Janssen et al., 2007).

Acute pancreatitis (AP) is one of the most frequent gastrointestinal causes for hospital admission in the US.

Chronic pancreatitis, although lower in incidence, significantly reduces patients' quality of life (yadav et al., 2013).

Pancreatic cancer has high mortality and is 1 of the top 5 causes of death from cancer. The burden of pancreatic disorders is expected to increase over time (yadav et al., 2013).

AP is an inflammatory condition of the pancreas presenting as abdominal pain and increased levels of pancreatic enzymes in the blood, most commonly caused by bile stones or excessive use of alcohol (Leppäniemi et al., 2019).

It has been associated with significant morbidity, mortality, and hospitalization costs (Janisch et al., 2016).

AP is a common disorder that leads to large number of admissions in Egypt and elsewhere in the world (Ahmed et al., 2016). The overall prevalence rate is 45.1 per 100,000 population (satoh et al., 2011). The severe form comprising about 20-30% of the patients with hospital mortality rates of about 15% (van santvoort et al., 2011).

Chronic pancreatitis (CP) is an inflammatory pancreatic disease characterized by pancreatic infiltration with inflammatory cells, progressive fibrosis, and loss of pancreatic parenchymal tissue (Ito et al., 2015). The global pooled incidence of CP is 40-50 per 100,000 general population per year (Xiao et al., 2016).

The diagnosis of CP is mainly based on the demonstration of the morphological and/or functional changes that develop during the course of the disease. CP is sometimes diagnosed at the progressed stage because no standard diagnostic criteria or method of diagnosing CP at an early stage has been established (Stevens et al., 2010).

As regard neoplastic lesions of pancreas, the global annual incidence rate for pancreas cancer is about 8/100,000 persons. Adenocarcinoma is the most frequent type of pancreatic cancer (Raimondi et al., 2009).

The overall age-adjusted pancreatic cancer mortality rate in Egypt was 1.47/100,000 population (Soliman et al., 2006).

The diagnosis of pancreatic pathology based on a combination of clinical signs and symptoms, imaging techniques and laboratory investigations (Lippi et al., 2012).

Imaging provides a significant contribution to the diagnosis as well as to the assessment of disease severity in patients with inflammatory pancreatic lesions, also can assess the neoplastic pancreatic lesions with accurate detection of extension and follow up of chemotherapeutic effects and survival prognosis (D'Onofrio et al., 2010; Lippi et al., 2012).

Imaging techniques for pancreatic diseases include ultrasound (US) B-mode, contrast enhanced computed tomography (CECT), magnetic resonance imaging (MRI), secretin-magnetic resonance cholangiopancreatography (S-MRCP), endoscopic ultrasonography (EUS), and endoscopic retrograde cholangiopancreatography (ERCP).

All the techniques have variable sensitivity and specificity, with certain disadvantages (Mateen et al., 2012).

Ultrasound B-mode (US) is effective in detection of etiological causes including presence of gallstones, common bile duct calculi, pseudocysts, pseudoaneurysm, and guiding percutaneous aspiration during the follow-up US also depicts the secondary signs for diagnosis of chronic pancreatitis like calcification and dilatation of pancreatic ducts (Munsell et al., 2010).

CECT is more accurate following the onset of acute pancreatitis in assessment and quantification of necrosis. Although MRI is superior to CECT in this respect, however CECT is less expensive and readily available (Mateen et al., 2012).

Typical CECT findings in acute pancreatitis include focal or diffuse enlargement of the pancreas, heterogeneous enhancement with irregular contour of the margins, increased density of peripancreatic fat planes, as well as the presence of intraperitoneal or retroperitoneal fluid collections (Lippi et al., 2012).

There's increasing use of ultrasound elastography for measuring tissue elasticity (hardness).

Shear wave elastography (SW-EG), a form of ultrasound elastography used in transabdominal ultrasonography, can measure tissue elasticity by generating shear waves inside the organ using the acoustic radiation force impulse (ARFI) (Hirooka et al., 2015; Kuwahara et al., 2016).

The ultrasound machine monitors shear wave propagation and measures the velocity. The shear wave velocity, displayed in kilopascals (kPa) or meters per second (Hirooka et al., 2015; Kuwahara et al., 2016).

Using ARFI, qualitative and quantitative determination of the tissue stiffness can be obtained (Bamber et al., 2013).

Qualitative assessment through generation of elastogram (gray scale or red-green-blue) map in which hard tissue areas are shown in black or dark blue, soft tissue areas in white or red and intermediate stiffness tissues are characterized by a yellow/green color indicator. There is no absolute scale of tissue stiffness (Göya et al., 2014).

Quantitative assessment generates numerical value related to the stiffness of tissue within the region of interest (Rees, 2008).

SW-EG is effective for the non-invasive assessment of liver fibrosis in patients with HCV infection especially in advanced stages (F3 and F4) (Moustafa et al., 2017) However, studies on the role of shear wave in a deep-seated organ like pancreas are limited (Hiroki et al., 2009; D'Onofrio et al., 2009).

Galloti et al. (2010) recorded normal values of shear-wave speed for healthy pancreas to be 1.40 m/s.

Another researcher group compared the diagnostic success of shear wave elastography with B-mode ultrasound and CT scan in patients with AP (Bollen et al., 2012).

They found that when using a cut-off value of 1.63 m/s, the sensitivity and specificity of VTQ for the diagnosis of AP were 100% and 98%, respectively (Bollen et al., 2012).

Also, D'Onofrio et al. (2009) diagnosed pancreatic cystadenoma, which mimicked a solid neoplasm at conventional imaging (US and CT), as cystic at shear wave imaging .

Kuwahara et al. (2018) stated that chronic pancreatitis may be diagnosed noninvasively and objectively using SW-EG without performing EUS.

Only a few studies that have assessed the normal range value for pancreatic stiffness, inflammatory and malignant pancreatic lesions; from this point of view, shear wave velocities of healthy parenchyma, acute and chronic pancreatitis, malignant lesions of the pancreas will be evaluated and compared.

Being tested
shear wave elastography
Keywords
shear wave elastography, pancreatic diseases
Medical subject headings
Pancreatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • shear wave elastographyDevice

    Shear wave elastography (SW-EG), a form of ultrasound elastography used in transabdominal ultrasonography, can measure 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

Study groups in NCT04964648
Study groupRoleWhat they receive
Inflammatory pancreatic lesionsolder than 18 years with a diagnosis of acute or chronic pancreatitis
Receives: Device: shear wave elastography
Malignant pancreatic lesionsolder than 18 years with a diagnosis of pancreatic neoplasm
Receives: Device: shear wave elastography
Control groupHealthy adult subjects
Receives: Device: shear wave elastography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. shear wave elastography (SWE) in diagnosis of inflammatory and malignant pancreatic diseases

    •To measure the shear wave velocity (displayed in kilopascals (kPa) or meters per second) of inflammatory and malignant pancreatic diseases

    Measured: Baseline

  2. •To compare the diagnostic success rate of shear wave elastography with other conventional imaging modalities

    •To compare the diagnostic success rate of shear wave elastography with those of sonography and computed tomography (CT) for inflammatory and malignant pancreatic diseases.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2021
  2. Study start10 Jul 2021 (estimated)
  3. Primary completion10 Jul 2022 (estimated)
  4. Study completion10 Jul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04964648
Sponsor's protocol ID
SW-EG in pancreatic diseases
Status last verified
Jul 2021
First submitted
3 Jul 2021
Last updated
16 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bamber J, Cosgrove D, Dietrich CF, Fromageau J, Bojunga J, Calliada F, Cantisani V, Correas JM, D'Onofrio M, Drakonaki EE, Fink M, Friedrich-Rust M, Gilja OH, Havre RF, Jenssen C, Klauser AS, Ohlinger R, Saftoiu A, Schaefer F, Sporea I, Piscaglia F. EFSUMB guidelines and recommendations on the clinical use of ultrasound elastography. Part 1: Basic principles and technology. Ultraschall Med. 2013 Apr;34(2):169-84. doi: 10.1055/s-0033-1335205. Epub 2013 Apr 4.

    PubMed 23558397
  • Bollen TL, Singh VK, Maurer R, Repas K, van Es HW, Banks PA, Mortele KJ. A comparative evaluation of radiologic and clinical scoring systems in the early prediction of severity in acute pancreatitis. Am J Gastroenterol. 2012 Apr;107(4):612-9. doi: 10.1038/ajg.2011.438. Epub 2011 Dec 20.

    PubMed 22186977
  • D'Onofrio M, Gallotti A, Martone E, Pozzi Mucelli R. Solid appearance of pancreatic serous cystadenoma diagnosed as cystic at ultrasound acoustic radiation force impulse imaging. JOP. 2009 Sep 4;10(5):543-6.

    PubMed 19734634
  • D'Onofrio M, Gallotti A, Pozzi Mucelli R. Imaging techniques in pancreatic tumors. Expert Rev Med Devices. 2010 Mar;7(2):257-73. doi: 10.1586/erd.09.67.

    PubMed 20214430
  • Moustafa EF, Makhlouf N, Hassany SM, Helmy A, Nasr A, Othman M, Seif H, Darwish M, Hassan H, Hessen M. Non-invasive assessment of liver fibrosis in patients with hepatitis C: Shear wave elastography and colour Doppler velocity profile technique versus liver biopsy. Arab J Gastroenterol. 2017 Mar;18(1):6-12. doi: 10.1016/j.ajg.2017.01.004. Epub 2017 Mar 3.

    PubMed 28262531
  • Friedrich-Rust M, Romen D, Vermehren J, Kriener S, Sadet D, Herrmann E, Zeuzem S, Bojunga J. Acoustic radiation force impulse-imaging and transient elastography for non-invasive assessment of liver fibrosis and steatosis in NAFLD. Eur J Radiol. 2012 Mar;81(3):e325-31. doi: 10.1016/j.ejrad.2011.10.029. Epub 2011 Nov 26.

    PubMed 22119555
  • Friedrich-Rust M, Wunder K, Kriener S, Sotoudeh F, Richter S, Bojunga J, Herrmann E, Poynard T, Dietrich CF, Vermehren J, Zeuzem S, Sarrazin C. Liver fibrosis in viral hepatitis: noninvasive assessment with acoustic radiation force impulse imaging versus transient elastography. Radiology. 2009 Aug;252(2):595-604. doi: 10.1148/radiol.2523081928.

    PubMed 19703889
  • Gallotti A, D'Onofrio M, Pozzi Mucelli R. Acoustic Radiation Force Impulse (ARFI) technique in ultrasound with Virtual Touch tissue quantification of the upper abdomen. Radiol Med. 2010 Sep;115(6):889-97. doi: 10.1007/s11547-010-0504-5. Epub 2010 Jan 15. English, Italian.

    PubMed 20082227
  • Goertz RS, Schuderer J, Strobel D, Pfeifer L, Neurath MF, Wildner D. Acoustic radiation force impulse shear wave elastography (ARFI) of acute and chronic pancreatitis and pancreatic tumor. Eur J Radiol. 2016 Dec;85(12):2211-2216. doi: 10.1016/j.ejrad.2016.10.019. Epub 2016 Oct 18.

    PubMed 27842669
  • Goya C, Hamidi C, Hattapoglu S, Cetincakmak MG, Teke M, Degirmenci MS, Kaya M, Bilici A. Use of acoustic radiation force impulse elastography to diagnose acute pancreatitis at hospital admission: comparison with sonography and computed tomography. J Ultrasound Med. 2014 Aug;33(8):1453-60. doi: 10.7863/ultra.33.8.1453.

    PubMed 25063411
  • Uchida H, Hirooka Y, Itoh A, Kawashima H, Hara K, Nonogaki K, Kasugai T, Ohno E, Ohmiya N, Niwa Y, Katano Y, Ishigami M, Goto H. Feasibility of tissue elastography using transcutaneous ultrasonography for the diagnosis of pancreatic diseases. Pancreas. 2009 Jan;38(1):17-22. doi: 10.1097/MPA.0b013e318184db78.

    PubMed 18695627
  • Hirooka Y, Kuwahara T, Irisawa A, Itokawa F, Uchida H, Sasahira N, Kawada N, Itoh Y, Shiina T. JSUM ultrasound elastography practice guidelines: pancreas. J Med Ultrason (2001). 2015 Apr;42(2):151-74. doi: 10.1007/s10396-014-0571-7. Epub 2014 Oct 8.

    PubMed 26576568
  • Ito T, Ishiguro H, Ohara H, Kamisawa T, Sakagami J, Sata N, Takeyama Y, Hirota M, Miyakawa H, Igarashi H, Lee L, Fujiyama T, Hijioka M, Ueda K, Tachibana Y, Sogame Y, Yasuda H, Kato R, Kataoka K, Shiratori K, Sugiyama M, Okazaki K, Kawa S, Tando Y, Kinoshita Y, Watanabe M, Shimosegawa T. Evidence-based clinical practice guidelines for chronic pancreatitis 2015. J Gastroenterol. 2016 Feb;51(2):85-92. doi: 10.1007/s00535-015-1149-x. Epub 2016 Jan 4.

    PubMed 26725837
  • Janisch NH, Gardner TB. Advances in Management of Acute Pancreatitis. Gastroenterol Clin North Am. 2016 Mar;45(1):1-8. doi: 10.1016/j.gtc.2015.10.004. Epub 2015 Dec 19.

    PubMed 26895677
  • Janssen J, Schlorer E, Greiner L. EUS elastography of the pancreas: feasibility and pattern description of the normal pancreas, chronic pancreatitis, and focal pancreatic lesions. Gastrointest Endosc. 2007 Jun;65(7):971-8. doi: 10.1016/j.gie.2006.12.057.

    PubMed 17531630

Questions about this trial

What is this clinical trial studying?

An observational study of Shear Wave Elastography and Pancreatic Diseases, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zeinab Ramadan, Assistant lecturer (01017800673, z.zedan@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

shear wave elastography (SWE) in diagnosis of inflammatory and malignant pancreatic diseases (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04964648, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.

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