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SpHincterotomy for Acute Recurrent Pancreatitis (SHARP)

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ClinicalTrials.gov Identifier: NCT03609944
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : April 22, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Gregory A. Cote, Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE July 24, 2018
First Posted Date  ICMJE August 1, 2018
Last Update Posted Date April 22, 2020
Actual Study Start Date  ICMJE September 27, 2018
Estimated Primary Completion Date February 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2018)
Reduce the risk of subsequent acute pancreatitis episodes by 33% [ Time Frame: This is a time-to-event outcome that is assessed starting 30 days after treatment through a maximum follow-up of 48 months. ]
To test this aim, compare the incidence of acute pancreatitis > 30 days after treatment allocation as the primary outcome measure, using the next attack of acute pancreatitis as a time-to-event outcome.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2018)
To compare the incidence rate ratio of acute pancreatitis between treatment groups [ Time Frame: Incidence rate will be assessed starting 30 days after treatment through a maximum follow-up of 48 months. ]
All randomized subjects will be followed longitudinally until study completion (minimum follow-up of six months, maximum follow-up of 48 months), even if acute pancreatitis occurs during follow-up. A secondary benefit of miES may be a reduction in acute pancreatitis frequency, defined as the incidence rate (episodes/time pre- and post-randomization). Since baseline incidence rate is a probable predictor of post-randomization incidence rate, the investigators will compare the incidence rate ratios between the two arms, keeping person-time equal between the pre/post periods.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SpHincterotomy for Acute Recurrent Pancreatitis
Official Title  ICMJE SpHincterotomy for Acute Recurrent Pancreatitis (SHARP Trial)
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Subjects will be randomized 1:1 to either EUS+sham or EUS+ERCP with miES.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
In addition to the participant and the investigator assessing outcomes, study coordinators involved in collecting outcomes data will be masked to the treatment assignment.
Primary Purpose: Treatment
Condition  ICMJE
  • Pancreatitis
  • Pancreas Divisum
  • Pancreatitis, Acute
  • Pancreatitis Idiopathic
  • Pancreas Inflamed
Intervention  ICMJE
  • Procedure: ERCP with miES
    Endoscopic retrograde cholangiopancreatography with minor papilla endoscopic sphincterotomy
  • Procedure: EUS
    Endoscopic ultrasound
Study Arms  ICMJE
  • Sham Comparator: EUS + Sham
    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.
    Intervention: Procedure: EUS
  • Experimental: EUS + ERCP with miES
    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.
    Interventions:
    • Procedure: ERCP with miES
    • Procedure: EUS
Publications * Coté 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 31, 2018)
234
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2023
Estimated Primary Completion Date February 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gregory Cote, MD, MS 843-792-6999 cotea@musc.edu
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT03609944
Other Study ID Numbers  ICMJE 1922
U01DK116743 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gregory A. Cote, Medical University of South Carolina
Study Sponsor  ICMJE Gregory A. Cote
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Study Chair: Gregory A Cote, MD, MS Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP