SpHincterotomy for Acute Recurrent Pancreatitis (SHARP)
Pancreatitis, Pancreas Divisum, Pancreatitis, Acute
About this trial
This is an interventional treatment trial for Pancreatitis focused on measuring ERCP, Endoscopic retrograde cholangiopancreatography, pancreatitis
Eligibility Criteria
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
Sites / Locations
- University of Arkansas for Medical SciencesRecruiting
- Keck Hospital of USCRecruiting
- Cedars-SinaiRecruiting
- UCSF Medical CenterRecruiting
- Yale School of MedicineRecruiting
- Emory University HospitalRecruiting
- Northwestern UniversityRecruiting
- Indiana UniversityRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- University of MinnesotaRecruiting
- Saint Luke's Hospital SystemRecruiting
- Dartmouth-Hitchcock Medical CenterRecruiting
- University of Rochester
- The Ohio State University - Wexner Medical CenterRecruiting
- Oregon Health and Science UniversityRecruiting
- University of Pittsburgh Medical CenterRecruiting
- Medical University of South CarolinaRecruiting
- Methodist Dallas Medical CenterRecruiting
- University of VirginiaRecruiting
- Virginia Mason Hospital & Seattle Medical CenterRecruiting
- Health Sciences CentreRecruiting
- Radboud University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Experimental
EUS + Sham
EUS + ERCP with miES
Subjects randomized to EUS + sham will undergo a diagnostic endoscopic ultrasound (EUS) under sedation. The physician investigator will not make any attempts to achieve minor papilla cannulation, but photo document the minor papilla using a duodenoscope. Diluted dye will be injected into the duodenum. A small caliber prophylactic pancreatic duct stent will be deposited into the duodenal lumen. These maneuvers are performed to minimize the risk of unmasking.
Subjects randomized to EUS + ERCP with miES will undergo the procedure at the same time as endoscopic ultrasound (EUS), under sedation. Indomethacin (100 mg) will be administered rectally at the onset of the ERCP procedure in patients with no known allergy to indomethacin. The techniques used to perform the endoscopic retrograde cholangiopancreatography (ERCP)with miES (minor papilla endoscopic sphincterotomy) will be left to the discretion of the study endoscopist. The extent of sphincterotomy will be per the discretion of the treating endoscopist. Unless methylene blue (or similar chromoendoscopy agent such as indigo carmine) has already been used to facilitate minor papilla cannulation, diluted dye will be injected into the duodenum.