SHARP

What is the Purpose of this Study?

This study focuses on patients who have been diagnosed with pancreas divisum and have had at least 2 episodes of pancreatitis. The purpose of the study is to determine whether 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 medical procedure that is often performed in patients with unexplained, recurrent acute pancreatitis who also have pancreas divisum. For the procedure, doctors use 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. A cut is made in the opening of the duct to allow better drainage of fluid from the pancreas. The goal of the procedure is to reduce the risk of future attacks of pancreatitis. Participants will be randomly assigned to have an endoscopic ultrasound plus an ERCP with sphincterotomy, or an endoscopic ultrasound plus a "sham" procedure (meaning participants will be treated as if they are having the ERCP with sphincterotomy, but the procedure will not really be performed).


Eligibility

  • 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:
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Sphincterotomy for acute recurrent pancreatitis trial

Study Details
Disease Type/Condition

Acute pancreatitis, Pancreatitis

Principal Investigator

Gaddam, Srinivas

Age Group

Adult

Phase

N/A

IRB Number

STUDY00000716

ClinicalTrials.gov ID

NCT03609944

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Acute pancreatitis, Pancreatitis

Principal Investigator

Gaddam, Srinivas

Age Group

Adult

Phase

N/A

IRB Number

SHARP

ClinicalTrials.gov ID

NCT03609944

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org