Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04611958 |
| Other study ID # |
IRB00268695 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2021 |
| Est. completion date |
July 1, 2021 |
Study information
| Verified date |
July 2021 |
| Source |
Johns Hopkins University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The major clinical features of chronic pancreatitis include glandular (exocrine and
endocrine) failure and pain. Pain has remained a major clinical challenge and is present in
up to 90% of patients and is the primary cause of hospitalization in most patients.
Unfortunately, pain in chronic pancreatitis has been very difficult to treat.
The investigators hypothesize that the best method to reliably abolish peripheral nerve
signaling is the use of a local anesthetic within the target organ (i.e. pancreas). This can
best be done during endoscopic retrograde cholangiopancreatography (ERCP).
Since ERCP is done under deep sedation or general anesthesia, it is critical to select a
local anesthetic whose effect persists well after recovery from the procedure; if not, the
assessment of the effect of the local anesthetic on pain will be impossible to assess. The
investigators have therefore chosen liposomal bupivacaine (Exparel, Pacira Pharmaceuticals),
which is an FDA approved product for local infiltration that has a longer duration of action
(up to 72 hours) and a slower absorption into the systemic circulation, avoiding high plasma
concentrations.
Description:
The major clinical features of chronic pancreatitis include glandular (exocrine and
endocrine) failure and pain. The former can usually be managed satisfactorily by replacement
strategies (enzymes or insulin) to restore nutritional and metabolic stability. However, pain
has remained a major clinical challenge and is present in up to 90% of patients and is the
primary cause of hospitalization in most patients. Unfortunately, pain in chronic
pancreatitis has been very difficult to treat, and the investigators' lack of understanding
about the underlying biology has led to various empirical approaches that are often based on
purely anatomical grounds, and are generally highly invasive. Significant tissue injury such
as that observed in chronic pancreatitis not only triggers nociceptor activation but over
time, can also increase the pain in the whole system, a process called sensitization.
Determination of the contribution of peripheral versus central factors to nociceptive
sensitization has significant clinical implications in an individual patient. Thus, if pain
is caused primarily by signals emanating in the peripheral nerves, then perhaps invasive
procedures directed against the pancreas (including pancreatectomy) are justified and can be
expected to have a high probability of success. On the other hand, if central sensitization
is the dominant pathophysiological factor, then these procedures may cause more harm than
good and the patient may be best served using aggressive neuromodulator therapies.
The most direct way to address this question is to interrupt peripheral nerve signaling and
determine how much of the pain, if any, is taken away. Unfortunately, there are no
satisfactory methods to do this currently. Although celiac or splanchnic nerve blocks have
been used for the treatment of pain in chronic pancreatitis, the treatments have had limited
success for a variety of reasons, including the fact that the technique may not always be
accurate in terms of the site of injection.
The investigators hypothesize that the best method to reliably abolish peripheral nerve
signaling is the use of a local anesthetic within the target organ (i.e. pancreas). This can
best be done during endoscopic retrograde cholangiopancreatography (ERCP), a technique in
which the main pancreatic duct is cannulated with the help of a duodenoscope and contrast
material injected. This technique is routinely done to assess pancreatic duct anatomy prior
to consideration of a therapeutic intervention such as a stent, stricture dilation, or stone
removal/lithotripsy.
Since ERCP is done under deep sedation or general anesthesia, it is critical to select a
local anesthetic whose effect persists well after recovery from the procedure; if not, the
assessment of the effect of the local anesthetic on pain will be impossible to assess. The
investigators have therefore chosen liposomal bupivacaine (Exparel, Pacira Pharmaceuticals),
which is an FDA approved product for local infiltration that has a longer duration of action
(up to 72 hours) and a slower absorption into the systemic circulation, avoiding high plasma
concentrations.
