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Shear Wave Elastography in Diagnosis of Inflammatory and Malignant Pancreatic Diseases

15 juillet 2021 mis à jour par: ZRMohamed, Assiut University

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Anticipé)

100

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Zeinab Ramadan, Assistant lecturer
  • Numéro de téléphone: 01017800673
  • E-mail: z.zedan@aun.edu.eg

Sauvegarde des contacts de l'étude

  • Nom: Zainab Gaber, Assistant professor
  • Numéro de téléphone: 01004496692
  • E-mail: zainabgaber@yahoo.com

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

N/A

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

  • 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.

La description

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).

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Inflammatory pancreatic lesions
older than 18 years with a diagnosis of acute or chronic pancreatitis
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
Malignant pancreatic lesions
older than 18 years with a diagnosis of pancreatic neoplasm
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
Control group
Healthy adult subjects
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
shear wave elastography (SWE) in diagnosis of inflammatory and malignant pancreatic diseases
Délai: Baseline
•To measure the shear wave velocity (displayed in kilopascals (kPa) or meters per second) of inflammatory and malignant pancreatic diseases
Baseline
•To compare the diagnostic success rate of shear wave elastography with other conventional imaging modalities
Délai: Baseline
•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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Anticipé)

10 juillet 2021

Achèvement primaire (Anticipé)

10 juillet 2022

Achèvement de l'étude (Anticipé)

10 juillet 2023

Dates d'inscription aux études

Première soumission

3 juillet 2021

Première soumission répondant aux critères de contrôle qualité

15 juillet 2021

Première publication (Réel)

16 juillet 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 juillet 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 juillet 2021

Dernière vérification

1 juillet 2021

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SW-EG in pancreatic diseases

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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