SpHincterotomy for Acute Recurrent Pancreatitis (SHARP)

  • STATUS
    Recruiting
  • End date
    Sep 1, 2025
  • participants needed
    234
  • sponsor
    Oregon Health and Science University
Updated on 14 July 2022
amylase
lipase
endoscopic ultrasound
abdominal pain
x-rays
serum lipase
chronic pancreatitis
endoscopic retrograde cholangiopancreatography
acute pancreatitis
acute recurrent pancreatitis

Summary

The purpose of this study is to determine if a procedure called Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincterotomy reduces the risk of pancreatitis or the number of recurrent pancreatitis episodes in patients with pancreas divisum. ERCP with sphincterotomy is a procedure where doctors used a combination of x-rays and an endoscope (a long flexible lighted tube) to find the opening of the duct where fluid drains out of the pancreas. People who have been diagnosed with pancreas divisum, have had at least two episodes of pancreatitis, and are candidates for the ERCP with sphincterotomy procedure may be eligible to participate. Participants will be will be randomly assigned to either have the ERCP with sphincterotomy procedure, or to have a "sham" procedure. Participants will have follow up visits 30 days after the procedure, 6 months after the procedure, and continuing every 6 months until a maximum follow-up period of 48 months.

Description

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).

Details
Condition Pancreatitis, Pancreas Divisum, Pancreatitis, Acute, Pancreatitis Idiopathic, Pancreas Inflamed
Treatment EUS, ERCP with miES
Clinical Study IdentifierNCT03609944
SponsorOregon Health and Science University
Last Modified on14 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient must consent to be in the study and must have signed and dated an approved consent form
>18 years
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
At least one episode of acute pancreatitis within 24 months of enrollment
Pancreas divisum confirmed by prior MRCP that is reviewed by an abdominal radiologist at the recruiting site
By physician assessment, there is no certain explanation for recurrent acute pancreatitis
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

Prior minor papilla therapy (endoscopic or surgical)
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
Main pancreatic duct stricture
Presence of a structural etiology for acute pancreatitis, such as anomalous pancreatobiliary union, periampullary mass, or pancreatic mass lesion on imaging
Presence of a local complication from acute pancreatitis which requires pancreatogram
Regular use of opioid medication for abdominal pain for the past three months
Medication as the etiology for acute pancreatitis by physician assessment
TWEAK score ≥ 4
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