Shear Wave Elastography in Diagnosis of Inflammatory and Malignant Pancreatic Diseases

Pancreatic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04964648
• Other study ID #: SW-EG in pancreatic diseases
• Status: Not yet recruiting
• Start date: July 10, 2021
• Est. completion date: July 10, 2023

Study information

• Verified date: July 2021
• Source: Assiut University
• Contact: Zeinab Ramadan, Assistant lecturer
• Phone: 01017800673
• Email: z.zedan[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical 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, and evaluate its role in assessment of severity and prediction of clinical course/ outcome in patients with inflammatory pancreatic diseases.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 10, 2023
• Est. primary completion date: July 10, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Inflammatory pancreatic lesions (acute or chronic pancreatitis)

2. Malignant pancreatic lesions

3. Healthy adult control

Exclusion Criteria:

1. Patient with difficult visualization of the pancreas on B-mode sonography.

2. Patients with acute liver diseases.

3. Obese patient (body mass index >30 kg/m2).

Related Conditions & MeSH terms

• Pancreatic Diseases

Intervention

Device:
• shear wave elastography
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (31)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Göya C, Hamidi C, Hattapoglu S, Çetinçakmak 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. Erratum in: J Ultrasound Med. 2014 Sep;33(9):1696. J Ultrasound Med. 2014 Sep;33(9):1696. — View Citation

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. Review. Erratum in: J Med Ultrason (2001). 2015 Apr;42(2):175. — View Citation

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. — View Citation

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. Review. — View Citation

Janssen J, Schlörer 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. — View Citation

Kaya M, Degirmenci S, Göya C, Tuncel ET, Uçmak F, Kaplan MA. The importance of acoustic radiation force impulse (ARFI) elastography in the diagnosis and clinical course of acute pancreatitis. Turk J Gastroenterol. 2018 May;29(3):342-347. doi: 10.5152/tjg.2018.17338. — View Citation

Kuwahara T, Hirooka Y, Kawashima H, Ohno E, Ishikawa T, Yamamura T, Furukawa K, Funasaka K, Nakamura M, Miyahara R, Watanabe O, Ishigami M, Hashimoto S, Goto H. Usefulness of shear wave elastography as a quantitative diagnosis of chronic pancreatitis. J Gastroenterol Hepatol. 2018 Mar;33(3):756-761. doi: 10.1111/jgh.13926. — View Citation

Kuwahara T, Hirooka Y, Kawashima H, Ohno E, Sugimoto H, Hayashi D, Morishima T, Kawai M, Suhara H, Takeyama T, Yamamura T, Funasaka K, Nakamura M, Miyahara R, Watanabe O, Ishigami M, Shimoyama Y, Nakamura S, Hashimoto S, Goto H. Quantitative evaluation of pancreatic tumor fibrosis using shear wave elastography. Pancreatology. 2016 Nov - Dec;16(6):1063-1068. doi: 10.1016/j.pan.2016.09.012. Epub 2016 Sep 23. — View Citation

Leppäniemi A, Tolonen M, Tarasconi A, Segovia-Lohse H, Gamberini E, Kirkpatrick AW, Ball CG, Parry N, Sartelli M, Wolbrink D, van Goor H, Baiocchi G, Ansaloni L, Biffl W, Coccolini F, Di Saverio S, Kluger Y, Moore E, Catena F. 2019 WSES guidelines for the management of severe acute pancreatitis. World J Emerg Surg. 2019 Jun 13;14:27. doi: 10.1186/s13017-019-0247-0. eCollection 2019. Review. — View Citation

Lippi G, Valentino M, Cervellin G. Laboratory diagnosis of acute pancreatitis: in search of the Holy Grail. Crit Rev Clin Lab Sci. 2012 Jan-Feb;49(1):18-31. doi: 10.3109/10408363.2012.658354. Review. — View Citation

Mateen MA, Muheet KA, Mohan RJ, Rao PN, Majaz HM, Rao GV, Reddy DN. Evaluation of ultrasound based acoustic radiation force impulse (ARFI) and eSie touch sonoelastography for diagnosis of inflammatory pancreatic diseases. JOP. 2012 Jan 10;13(1):36-44. — View Citation

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. — View Citation

Munsell MA, Buscaglia JM. Acute pancreatitis. J Hosp Med. 2010 Apr;5(4):241-50. doi: 10.1002/jhm.574. Review. — View Citation

Raimondi S, Maisonneuve P, Lowenfels AB. Epidemiology of pancreatic cancer: an overview. Nat Rev Gastroenterol Hepatol. 2009 Dec;6(12):699-708. doi: 10.1038/nrgastro.2009.177. Epub 2009 Oct 6. Review. — View Citation

Satoh K, Shimosegawa T, Masamune A, Hirota M, Kikuta K, Kihara Y, Kuriyama S, Tsuji I, Satoh A, Hamada S; Research Committee of Intractable Diseases of the Pancreas. Nationwide epidemiological survey of acute pancreatitis in Japan. Pancreas. 2011 May;40(4):503-7. doi: 10.1097/MPA.0b013e318214812b. — View Citation

Schreyer AG, Jung M, Riemann JF, Niessen C, Pregler B, Grenacher L, Hoffmeister A; German Society of Digestive and Metabolic Diseases (DGVS). S3 guideline for chronic pancreatitis - diagnosis, classification and therapy for the radiologist. Rofo. 2014 Nov;186(11):1002-8. doi: 10.1055/s-0034-1385005. Epub 2014 Aug 14. — View Citation

Soliman AS, Zhang Q, Saleh T, Zarzour A, Selim M, Abdel-Fattah M, Abbruzzese JL. Pancreatic cancer mortality in Egypt: comparison to the United States pancreatic cancer mortality rates. Cancer Detect Prev. 2006;30(5):473-9. Epub 2006 Oct 25. — View Citation

Stevens T, Lopez R, Adler DG, Al-Haddad MA, Conway J, Dewitt JM, Forsmark CE, Kahaleh M, Lee LS, Levy MJ, Mishra G, Piraka CR, Papachristou GI, Shah RJ, Topazian MD, Vargo JJ, Vela SA. Multicenter comparison of the interobserver agreement of standard EUS scoring and Rosemont classification scoring for diagnosis of chronic pancreatitis. Gastrointest Endosc. 2010 Mar;71(3):519-26. doi: 10.1016/j.gie.2009.10.043. — View Citation

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. — View Citation

van Santvoort HC, Bakker OJ, Bollen TL, Besselink MG, Ahmed Ali U, Schrijver AM, Boermeester MA, van Goor H, Dejong CH, van Eijck CH, van Ramshorst B, Schaapherder AF, van der Harst E, Hofker S, Nieuwenhuijs VB, Brink MA, Kruyt PM, Manusama ER, van der Schelling GP, Karsten T, Hesselink EJ, van Laarhoven CJ, Rosman C, Bosscha K, de Wit RJ, Houdijk AP, Cuesta MA, Wahab PJ, Gooszen HG; Dutch Pancreatitis Study Group. A conservative and minimally invasive approach to necrotizing pancreatitis improves outcome. Gastroenterology. 2011 Oct;141(4):1254-63. doi: 10.1053/j.gastro.2011.06.073. Epub 2011 Jul 8. — View Citation

Xiao AY, Tan ML, Wu LM, Asrani VM, Windsor JA, Yadav D, Petrov MS. Global incidence and mortality of pancreatic diseases: a systematic review, meta-analysis, and meta-regression of population-based cohort studies. Lancet Gastroenterol Hepatol. 2016 Sep;1(1):45-55. doi: 10.1016/S2468-1253(16)30004-8. Epub 2016 Jun 28. Review. — View Citation

Yadav D, Lowenfels AB. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology. 2013 Jun;144(6):1252-61. doi: 10.1053/j.gastro.2013.01.068. Review. — View Citation

Yadav D, Timmons L, Benson JT, Dierkhising RA, Chari ST. Incidence, prevalence, and survival of chronic pancreatitis: a population-based study. Am J Gastroenterol. 2011 Dec;106(12):2192-9. doi: 10.1038/ajg.2011.328. Epub 2011 Sep 27. Erratum in: Am J Gastroenterol. 2011 Dec;106(12):2209. — View Citation

* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline
Primary	•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.	Baseline