Elastography in the Diagnosis of Chronic Pancreatitis

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Brief Title

Elastography in the Diagnosis of Chronic Pancreatitis

Official Title

Elastography in the Diagnosis of Chronic Pancreatitis

Brief Summary

      Chronic pancreatitis is a progressive inflammatory condition where progressive fibrosis and
      calcification results in loss of physiological pancreatic function (both endocrine and
      exocrine). The structural, fibrotic changes of chronic pancreatitis can only be seen in
      advanced disease with conventional radiology tests and the diagnosis of chronic pancreatitis
      early in the disease course remains challenging. Early diagnosis and treatment of chronic
      pancreatitis can prevent the complications of pain and malnutrition and improve the quality
      of life of patients. Endoscopic ultrasound (EUS) has recently become a favoured method for
      diagnosing early structural fibrotic changes of chronic pancreatitis in clinical practice;
      however this technique is subjective with sub-optimal intra-observer agreement. A new
      technique called elastography, performed during EUS, quantitatively measures tissue stiffness
      which may give more reliable results. This study aims to assess whether EUS elastography can
      accurately identify for chronic pancreatitis.

      Patients referred for EUS examinations will be identified and recruited prospectively. The
      investigators will perform endoscopic ultrasound examinations with elastography readings in
      two groups of patients: those referred for EUS with suspicion of chronic pancreatitis and
      those referred for EUS for assessment of abdominal pain without risk factors or any other
      tests suggesting chronic pancreatitis. The elastography readings will then be compared to the
      gold standard which is a composite evaluation including standard EUS examination using
      morphological appearance (Rosemont classification), and other tests already performed
      including cross-sectional imaging (MRCP and CT), patient history and faecal pancreatic
      elastase (FEL-1).

      Patients will be identified and data collected prospectively. There is no randomization or
      blinding involved in the study as the endoscopists will need to be aware of the indication
      for referral in order to carry out a complete examination.
    

Detailed Description

      Chronic pancreatitis is a chronic inflammatory condition where progressive fibrosis and
      scarring leads to loss of pancreatic exocrine and endocrine function and can lead to
      development of malnutrition, weight loss, abdominal pain and impaired quality of life.
      Patients with chronic pancreatitis have a high risk of pancreatic adenocarcinoma compared to
      the general population so it is vital that they are identified early in the disease. There
      are numerous causes of chronic pancreatitis therefore early detection and treatment can
      prevent irreversible changes and symptoms developing.

      Trans-abdominal ultrasound (US), computed tomography (CT) and magnetic resonance imaging
      (MRI) are currently used to investigate patients with symptoms suggestive of chronic
      pancreatitis. These tests may, however, fail to show early changes in the bile ducts or small
      areas of inflammation in pancreatic tissue. In areas of diagnostic uncertainty, endoscopic
      ultrasound (EUS) is currently used to provide a more detailed assessment.

      EUS uses a flexible endoscope (similar to a gastroscope) passed into the stomach via the
      mouth. The EUS scope has the addition of a tiny ultrasound probe on the tip which is used to
      acquire high resolution detailed images of the pancreas and other extra luminal structures
      (lymph nodes, bile ducts, mediastinum) lying only centimeters from the tip of the probe.
      Despite the advantages of EUS, image interpretation can be extremely challenging and in the
      presence of inflammation. Morphological changes of chronic pancreatitis seen at EUS have been
      classified according to the Rosemont classification; however, the findings are subjective
      with sub-optimal intra-observer agreement.

      Elastography is an ultrasound technique used to assess stiffness of tissues in the body. It
      has established applications in detecting chronic liver disease, and improving diagnostic
      accuracy in breast and prostate cancers. Pancreatic elastography is now able to be performed
      during a standard EUS examination using the existing equipment (in a similar manner to
      Doppler). Tissue elasticity is measured and represented with different colours (on a scale of
      1 to 255). The colour signal (red-green-blue) is then superimposed on the conventional
      grey-scale image. Areas of increased stiffness are marked with dark blue, intermediate areas
      with green and soft tissue areas with red. Areas of interest are able to be marked to give an
      elasticity reading and this is also compared to a control area of stomach wall to calculate a
      ratio (strain ratio).

      Elastography has now become part of the routine EUS exam following several studies that have
      shown elastography can be successfully used to identify malignant pancreatic and lymph node
      masses with high sensitivity allowing accurate targeting of fine needle aspiration (FNA)
      biopsies and early confirmation or exclusion of cancer.

      The investigators hypothesise that changes of chronic pancreatitis can also be detected using
      elastography assisted EUS. Detecting change at an early stage will benefit patients and
      potentially reduce complications that result from chronic pancreatitis such as malnutrition,
      pain and osteoporosis.
    


Study Type

Interventional


Primary Outcome

Elastography strain ratios


Condition

Pancreatitis, Chronic

Intervention

Endoscopic ultrasound elastography

Study Arms / Comparison Groups

 suspected chronic pancreatitis patients
Description:  Patients with suspected chronic pancreatitis will undergo Endoscopic ultrasound elastography to assess whether this detects chronic pancreatitis.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

104

Start Date

November 29, 2016

Completion Date

April 14, 2022

Primary Completion Date

November 27, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Age 18 or over,

          -  Patients referred for EUS for investigation of abdominal pain without a cause found on
             assessment with MRI and FEL-1.

          -  Patients referred for EUS for chronic pancreatitis assessment based on MRI and/or
             FEL-1 testing.

        Exclusion Criteria:

          -  Patients with known solid pancreatic lesions

          -  Patients under the age of 18

          -  Patients who decline EUS examination

          -  Patients referred for EUS with indications other than epigastric pain or suspicion of
             chronic pancreatitis
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jennifer Campbell, 01142665911, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03173118

Organization ID

STH19471


Responsible Party

Sponsor

Study Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust


Study Sponsor

Jennifer Campbell, Principal Investigator, Sheffield Teaching Hospitals NHS FT


Verification Date

October 2020