Pancreas Divisum (PDiv), a congenital malunion of the dorsal and ventral pancreas, leaving the dorsal pancreas to drain through a small opening, the minor papilla (MinP), occurs in 10% of people;depending on genetics and environment, a subgroup may get recurrent acute pancreatitis (RAP). Endoscopic ultrasound (EUS) and (secretin-stimulated-) magnetic resonance cholangiopancreatography ((ss-)MRCP) can detect PDiv. A small (n=19) randomized trial of ERCP (endoscopic retrograde cholangiopancreatography) showed longterm MinP stenting reduces RAP (78% vs 10%), but longterm stenting is no longer used. ERCPists now cut the orifice open with cautery (MinP endoscopic sphincterotomy (MPES));MPES reduces recurrence to 8-40%. Many experts are not convinced MPES reduces RAP and do not refer for ERCP. A large, longterm (5-yr), randomized sham-controlled trial, studying Frequency of Recurrent Acute pancreatitis after Minor papilla Endo-scopic Sphincterotomy (the FRAMES trial), is needed to change their practice and confirm that ERCP is worth the cost and risks. Planning this trial, it was apparent that certain pilot data were needed.
SPECIFIC AIMS : To establish the volume of eligible patients, frequency of certain exclusions (esp. chronic pain, prior MPES), and prevalence of certain confounders;to gather data to standardize MPES technique;to estimate the accuracy of (ss-)MRCP and EUS for PDiv;to obtain blood for genetics, as predicting MPES efficacy genetically is also a novel concept. RESEARCH METHODS: 30 PDiv patients with IRAP (5 from each of 6 sites (MUSC, Indiana U., U. Alabama, Texas, Milwaukee, U. Minnesota)) will be recruited over 1 yr and followed for 6 mos, using inclusion criteria from the proposed FRAMES study, noting reasons for screen-fails and prevalence of confounders (e.g. chronic pancreatitis, gallbladder). Baseline and 6-mo quality of life and disability from interval pain (using the RAPID (Recurrent Abdominal Pain Intensity and Disability) score) will be measured. The proposed 1o outcome of the FRAMES trial, recurrence of acute pancreatitis, will be captured via telephone contact every 3 mos. Accuracy of pre-ERCP imaging ((ss-) MRCP, EUS) for PDiv will be estimated. MPES technique (needle- knife vs pull-type) will be noted and video-taped;acceptability (to ERCPist ) of the alternate technique for each patient will be recorded. Blood will be obtained for NIH repository and genetic testing (U. Pittsburg). Patients (2/site) with the chronic pain exclusion will be followed. FUTURE DIRECTIONS: The information obtained here in this pilot will answer critical questions to the planning of the randomized (2:1) sham-controlled multicenter FRAMES trial (n=130).

Public Health Relevance

Ten percent of people are born with a type of anatomy of the pancreas duct called Pancreas Divisum that might lead to recurrent acute pancreatitis (a condition that causes abdominal pain and can rarely be fatal). A randomized trial is needed to see if improving the drainage of the pancreas, using an endoscopic procedure called ERCP, can reduce the chances of future pancreatitis. This 6-center pilot study answers critical questions needed to plan that multicenter randomized trial.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Exploratory/Developmental Grants (R21)
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Clinical and Integrative Gastrointestinal Pathobiology Study Section (CIGP)
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Serrano, Jose
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Medical University of South Carolina
Internal Medicine/Medicine
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United States
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