SpHincterotomy for Acute Recurrent Pancreatitis

This is a sham-controlled, single blinded with a blinded outcome assessment, multi-center,
randomized clinical trial of endoscopic retrograde cholangiopancreatography (ERCP) with minor
papilla endoscopic sphincterotomy (miES) for the treatment of recurrent acute pancreatitis
(RAP) with pancreas divisum. ERCP with miES is often offered in clinical practice to patients
with RAP, pancreas divisum, and no other clear risk factors for their acute pancreatitis
episodes. The hypothesis is that obstruction at the level of the minor papilla is one cause
of RAP in pancreas divisum; miES will relieve the obstruction, thereby reducing the risk of a
recurrent attack(s) of acute pancreatitis. The trial requires a total sample size of
approximately 234 subjects, and a planned enrollment period of approximately 3.5 years with
total planned study duration of 5 years (minimum follow-up of 6 months, maximum follow-up of
48 months).

Inclusion Criteria:

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
ultrasonography

4. 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

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