Clinical trial NCT03609944: SpHincterotomy for Acute Recurrent Pancreatitis
Official title: SpHincterotomy for Acute Recurrent Pancreatitis (SHARP Trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreatitis
Pancreas Divisum
Pancreatitis, Acute
Pancreatitis Idiopathic
Pancreas Inflamed
Keywords: ERCP
Endoscopic retrograde cholangiopancreatography
pancreatitis
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-08-01
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized 1:1 to either EUS+sham or EUS+ERCP with miES.
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Reduce the risk of subsequent acute pancreatitis episodes by 33%
timeFrame: This is a time-to-event outcome that is assessed starting 30 days after treatment through a maximum follow-up of 48 months.
Secondary outcomes:
measure: To compare the incidence rate ratio of acute pancreatitis between treatment groups
timeFrame: Incidence rate will be assessed starting 30 days after treatment through a maximum follow-up of 48 months.
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Hospital System
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Columbus
country: United States
facility: The Ohio State University - Wexner Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Hospital & Seattle Medical Center
state: Washington
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
affiliation: Oregon Health and Science University
name: Gregory A Cote, MD, MS
role: STUDY_CHAIR
References:
citation: Cote GA, Durkalski-Mauldin VL, Serrano J, Klintworth E, Williams AW, Cruz-Monserrate Z, Arain M, Buxbaum JL, Conwell DL, Fogel EL, Freeman ML, Gardner TB, van Geenen E, Groce JR, Jonnalagadda SS, Keswani RN, Menon S, Moffatt DC, Papachristou GI, Ross A, Tarnasky PR, Wang AY, Wilcox CM, Hamilton F, Yadav D; SHARP Consortium. SpHincterotomy for Acute Recurrent Pancreatitis Randomized Trial: Rationale, Methodology, and Potential Implications. Pancreas. 2019 Sep;48(8):1061-1067. doi: 10.1097/MPA.0000000000001370.