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Procedure

Sphincterotomy for Acute Recurrent Pancreatitis (SHARP Trial)

N/A

Recruiting

Research Sponsored by Gregory A. Cote

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pancreas divisum confirmed by prior MRCP that is reviewed by an abdominal radiologist at the recruiting site

Age >18 years

Must not have

Presence of a structural etiology for acute pancreatitis, such as anomalous pancreatobiliary union, periampullary mass, or pancreatic mass lesion on imaging

Main pancreatic duct stricture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this is a time-to-event outcome that is assessed starting 30 days after treatment through a maximum follow-up of 48 months.

Summary

This trial is testing whether a procedure called ERCP with sphincterotomy reduces the risk of pancreatitis or the number of recurrent pancreatitis episodes in patients with pancreas divisum.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from ERCP with sphincterotomy may include discomfort, infection, bleeding, inflammation of the pancreas (pancreatitis), and rarely more serious complications like perforation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a narrowed main pancreatic duct.

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I need a special scan for a pancreas problem caused by inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ incidence rate will be assessed starting 30 days after treatment through a maximum follow-up of 48 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~incidence rate will be assessed starting 30 days after treatment through a maximum follow-up of 48 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and incidence rate will be assessed starting 30 days after treatment through a maximum follow-up of 48 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reduce the risk of subsequent acute pancreatitis episodes by 33%

Secondary study objectives

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

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EUS

2008

Completed Phase 4

~460

0 / 5Eligibility criteria met