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Compensation: Varies

Number of Visits: 31

Duration: 1 day

181 Participants Needed

Sphincterotomy for Acute Recurrent Pancreatitis
(SHARP Trial)

Recruiting at 21 trial locations

Overseen ByHeather Katcher

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Gregory A. Cote

Must not be taking: Opioids

Disqualifiers: Prior papilla therapy, Chronic pancreatitis, Pancreatic duct stricture, Structural etiology, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if your medication is identified as a cause of your pancreatitis, you may not be eligible to participate.

Is sphincterotomy generally safe for humans?

Sphincterotomy, often done during a procedure called ERCP, can have side effects like bleeding and pancreatitis (inflammation of the pancreas). These side effects occur in about 10% of cases, with bleeding being the most common issue.¹ ² ³ ⁴ ⁵

How does the treatment ERCP with sphincterotomy differ from other treatments for acute recurrent pancreatitis?

ERCP with sphincterotomy is unique because it involves a procedure to cut the muscle around the bile or pancreatic duct to help remove blockages, which can be particularly effective in severe cases of pancreatitis caused by gallstones. This treatment is different from surgery like cholecystectomy, as it is less invasive and can be performed endoscopically, but it carries risks such as pancreatitis, bleeding, and perforation.⁵ ⁶ ⁷ ⁸ ⁹

What data supports the effectiveness of the treatment ERCP with sphincterotomy for acute recurrent pancreatitis?

Research shows that endoscopic sphincterotomy, a procedure to cut the muscle between the bile duct and the pancreas, can quickly relieve pain and improve symptoms in patients with pancreatitis caused by gallstones. In studies, patients experienced rapid improvement and normalization of enzyme levels after the procedure, suggesting its effectiveness in treating similar conditions.⁵ ⁸ ¹⁰ ¹¹ ¹²

Who Is on the Research Team?

Gregory A Cote, MD, MS

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had at least two episodes of acute pancreatitis within the last 24 months, confirmed pancreas divisum, and no clear cause for their condition. They must be able to participate fully in the study and have not undergone any prior minor papilla therapy or regularly used opioids for abdominal pain.

Inclusion Criteria

I have had an acute pancreatitis episode in the last 2 years.

My pancreas divisum was confirmed by an MRCP reviewed by a specialist.

I have had at least two acute pancreatitis attacks confirmed by pain, high enzyme levels, or imaging.

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Exclusion Criteria

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

My acute pancreatitis is caused by a structural issue seen in imaging tests.

I have a narrowed main pancreatic duct.

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either the ERCP with sphincterotomy procedure or a sham procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 months

Follow-up visits at 30 days, 6 months, and every 6 months thereafter

What Are the Treatments Tested in This Trial?

Interventions

ERCP with sphincterotomy

Trial Overview The study tests if ERCP with sphincterotomy can reduce pancreatitis risk or recurrence in patients with pancreas divisum. Participants are randomly assigned to receive either the actual procedure or a sham (fake) procedure, followed up at intervals until a maximum of 48 months.

How Is the Trial Designed?

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EUS + ERCP with miESExperimental Treatment2 Interventions

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.

Group II: EUS + ShamPlacebo Group1 Intervention

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.