SpHincterotomy for Acute Recurrent Pancreatitis
- Conditions
- Pancreas divisum10017998
- Registration Number
- NL-OMON48117
- Lead Sponsor
- Medical University of South Carolina
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
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
enrollment
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
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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
imaging*
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1.Reduce the risk of subsequent acute pancreatitis:<br /><br>To test this aim, compare the incidence of acute pancreatitis > 30 days after<br /><br>treatment allocation as the primary outcome measure, using the next attack of<br /><br>acute pancreatitis as a time-to-event outcome.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Incidence rate ratio.<br /><br>Patient-reported outcomes<br /><br>Progression to chronic pancreatitis<br /><br>Biorepository</p><br>