Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03173118 |
| Other study ID # |
STH19471 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 29, 2016 |
| Est. completion date |
November 29, 2019 |
Study information
| Verified date |
April 2024 |
| Source |
Sheffield Teaching Hospitals NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
