Chronic Pancreatitis Clinical Trial
Official title:
Study to Assess Pancreatic Blood Flow at Rest and During Stimulation Using Magnetic Resonance Imaging (fMRI) in Patients With Chronic Pancreatitis
The purpose of this study is to assess pancreatic perfusion in patients with chronic pancreatitis at rest and after secretin stimulation and compare this to published data on pancreatic perfusion in normal subjects.
Pancreatic blood flow or perfusion is difficult to quantify due to the complex vascular
supply to the organ and its retroperitoneal location, adjacent to the abdominal aorta. The
pancreas is supplied by the superior gastroduodenal artery from the celiac plexus, branches
from the hepatic and splenic arteries, which originate from the celiac plexus, and the
inferior gastroduodenal artery, which originates from the superior mesenteric artery.
Identifying changes in flow in all these vessels with good spatial and temporal resolution
is challenging but important in understanding many of the chronic conditions of the
pancreas.
Chronic pancreatitis (CP) is an inflammatory condition of the pancreas leading to
irreversible damage to the tissue. It is increasing in incidence in all nations, and is
related to rising alcohol consumption and improved diagnostic techniques. In Europe the
incidence is approximately 6-7/100,000 population. 73-91% of patients affected are male with
an average age of 49-60yrs. Patients affected by CP have a high morbidity, such as diabetes
and chronic abdominal and/or post-prandial pain in 80-90%, which required frequent hospital
admission, control-drug prescriptions and intervention by specialist hospital services.
However the mechanisms of chronic and post-prandial pain for CP patients are not well
understood, but tissue ischaemia, inflammation and neurological changes have been proposed.
These mechanisms may be inter-related with pancreatic inflammation and neurochemical
changes, such as an increase substance P, which can produce vasoconstriction, reducing
pancreatic perfusion and worsening ischaemia of intra-pancreatic nerves(3). A greater
understanding of the ischaemic and inflammatory mechanisms behind the pain in CP, would
greatly enhance the development of treatment for this and other debilitating conditions.
There are a few studies of pancreatic tissue perfusion in humans, those studies which have
assessed perfusion have used invasive techniques such as endoscopic or laparoscopic
measurement and hydrogen gas clearance methods. Although these methods have demonstrated
decreased resting blood flow and little response to secretin stimulation in CP patients
compared to healthy controls, the techniques are highly invasive, time consuming and
expensive and can cause the participant significant morbidity. This has led to several
non-invasive techniques including infusion of oxygen-15 water and positron emission
tomography (PET), contrast-material-enhanced trans-abdominal ultrasound (US) or
contrast-enhanced dynamic computer tomography (CT). However these techniques involve
infusion of an exogenous marker to detect the change in flow rate and often require a
radiation exposure or are operator dependant and give poor spatial or temporal resolution,
limiting the usefulness of the studies.
MRI is an attractive alternative for the assessment of pancreatic perfusion, providing good
spatial and temporal resolution with no radiation exposure. Two methods can be used,
Contrast-Enhanced (CE) MRI or Arterial Spin Labelling (ASL) techniques. ASL provides a tool
for quantitative assessment of tissue perfusion without the need for contrast
administration.
Contrast-enhanced MRI using gadodiamide has been used to explore the changes in pancreatic
perfusion with secretin stimulation. This study in 10 healthy volunteers demonstrated that
at rest there was a higher blood flow within the body and the tail of the pancreas, compared
to the head. With secretin stimulation there was a significant increased perfusion in all
regions of the pancreas. ASL techniques, do not require exogenous contrast agents, only two
previous studies have measured pancreatic perfusion with ASL, one exploring pancreatic
exocrine functions in type 1 diabetics. A recent study at the Nottingham Digestive Diseases
Centre on pancreatic perfusion measurement using ASL at baseline and after intravenous
secretin stimulation has standardised the MRI technique of measuring pancreatic perfusion.
There are no studies using MRI ASL to measure pancreatic perfusion in patients with chronic
pancreatitis after secretin stimulation. This pilot study aims to test the feasibility of
using MRI ASL to measure pancreatic perfusion in patients with chronic pancreatitis with a
view to perfecting the technique. This will allow future studies comparing pancreatic
perfusion in healthy adult controls to patients with chronic pancreatitis thus improving the
investigators understanding of the pathophysiology of pain in patients with chronic
pancreatitis.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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