SpHincterotomy for Acute Recurrent Pancreatitis - SHARP-trial

Medical University of South Carolina0 sites10 target enrollmentStarted: TBDLast updated: April 15, 2024

Conditions

Trial Snapshot

No summary available.

•1.Patient must consent to be in the study and must have signed and dated an
•approved consent form.
•2.>18 years
•3.Two or more episodes of acute pancreatitis, with each episode meeting two of
•the following three criteria:
•*abdominal pain consistent with acute pancreatitis (acute onset of a
•persistent, severe, epigastric pain often radiating to the back)
•*serum lipase activity (or amylase activity) at least three times greater than
•the upper limit of normal
•*characteristic findings of acute pancreatitis on CECT, MRI or transabdominal
•ultrasonography4.At least one episode of acute pancreatitis within 24 months of
•5.Pancreas divisum confirmed by prior MRCP that is reviewed by an abdominal
•radiologist at the recruiting site.
•6.By physician assessment, there is no certain explanation for recurrent acute
•pancreatitis.
•7.Subjects must be able to fully understand and participate in all aspects of
•the study, including completion of questionnaires and telephone interviews, in
•the opinion of the clinical investigator

•Exclusion Criteria:
•1.Prior minor papilla therapy (endoscopic or surgical)
•2.Calcific chronic pancreatitis, defined as parenchymal or ductal
•calcifications identified on computed tomography or magnetic resonance imaging
•scan that is reviewed by an expert radiologist at the recruiting site.
•3.Main pancreatic duct stricture*
•4.Presence of a structural etiology for acute pancreatitis, such as anomalous
•pancreatobiliary union, periampullary mass, or pancreatic mass lesion on
•5.Presence of a local complication from acute pancreatitis which requires
•pancreatogram
•6.Regular use of opioid medication for abdominal pain for the past three months
•7.Medication as the etiology for acute pancreatitis by physician assessment
•8.TWEAK score >= 4

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