Intraductal Liposomal Bupivacaine for Chronic Pancreatitis
Withdrawn before enrolling · Early Phase 1
Conditions studied: Chronic Pancreatitis
In brief
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.
Key facts
- Study ID
- NCT04611958
- Run by
- Johns Hopkins University
- People needed
- 0
- Starts
- 2021-07-01
- Expected to finish
- 2021-07-01
- Last updated by the study team
- 2021-07-21
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Signed Informed consent
- Age >18 years
- Patients with an established diagnosis of chronic pancreatitis with constant daily pain consistent with the same and not relieved despite standard clinical care for at least 6 months and in whom ERCP is indicated for standard of care.
You may not qualify if…
- Significant liver or renal dysfunction.
- Any Contraindication of ERCP.
Where it is running
- Johns Hopkins Hopital — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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