SpHincterotomy for Acute Recurrent Pancreatitis

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Brief Title

SpHincterotomy for Acute Recurrent Pancreatitis

Official Title

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

Interventional


Primary Outcome

Reduce the risk of subsequent acute pancreatitis episodes by 33%

Secondary Outcome

 To compare the incidence rate ratio of acute pancreatitis between treatment groups

Condition

Pancreatitis

Intervention

ERCP with miES

Study Arms / Comparison Groups

 EUS + Sham
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

234

Start Date

September 27, 2018

Completion Date

September 1, 2024

Primary Completion Date

February 1, 2024

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Gregory A Cote, MD, MS, 843-792-6999, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT03609944

Organization ID

1922

Secondary IDs

U01DK116743

Responsible Party

Sponsor-Investigator

Study Sponsor

Gregory A. Cote

Collaborators

 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Sponsor

Gregory A Cote, MD, MS, Study Chair, Medical University of South Carolina


Verification Date

May 2021