Sphincterotomy for Acute Recurrent Pancreatitis

(SHARP Trial)

Not currently recruiting at 21 trial locations

Overseen By Heather 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a procedure called ERCP with sphincterotomy can reduce the risk or frequency of pancreatitis episodes in individuals with pancreas divisum. ERCP with sphincterotomy uses an endoscope (a flexible, lighted tube) and x-rays to locate and open the pancreatic duct, improving fluid drainage. Participants will receive either this procedure or a "sham" procedure for comparison. This trial may suit those diagnosed with pancreas divisum, who have experienced at least two episodes of pancreatitis, and are eligible for the ERCP procedure. As an unphased trial, it offers a unique opportunity to contribute to understanding a potential treatment for pancreas divisum.

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.

What prior data suggests that the ERCP with sphincterotomy procedure is safe for patients with pancreas divisum?

Research has shown that ERCP with sphincterotomy is generally safe for patients. One study found that about 7.8% of patients experienced complications soon after the procedure, with a few encountering issues later. However, most patients, approximately 94%, did not face major problems. This indicates that while some risk exists, the procedure is usually well-tolerated.

ERCP is often used to treat conditions like pancreatitis and has proven effective for many individuals. However, every medical procedure carries some risk. Participants should consult their doctors to understand the benefits and risks specific to their situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the technique of ERCP with minor papilla endoscopic sphincterotomy (miES) for acute recurrent pancreatitis because it offers a new approach to managing a challenging condition. Unlike standard treatments like pain management, dietary changes, or surgery, miES provides a targeted procedure that directly addresses the potential cause of recurrent pancreatitis. This technique allows for precise intervention during an endoscopic ultrasound, potentially reducing inflammation and preventing future episodes. Additionally, the use of indomethacin during the procedure might help minimize complications, making it a promising option for patients who haven't found relief with traditional methods.

What evidence suggests that ERCP with sphincterotomy is effective for reducing recurrent pancreatitis in patients with pancreas divisum?

Research has shown that a procedure called ERCP with sphincterotomy can help prevent the recurrence of pancreatitis. One study found that 94% of patients who underwent this procedure did not experience another episode over approximately 3.5 years. Another study reported effectiveness in 92.5% of cases, providing long-term relief. In this trial, participants will be randomized to receive either ERCP with minor papilla endoscopic sphincterotomy (miES) or a sham procedure. These findings suggest that ERCP with sphincterotomy could be a viable option for individuals who frequently experience pancreatitis, particularly those with a condition called pancreas divisum. However, limited data currently exist, so further research is necessary. ^{1 2 4 6 7}

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.

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.

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?

Group I: EUS + ERCP with miES Experimental Treatment 2 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 + Sham Placebo Group 1 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.

Who Is Running the Clinical Trial?

Gregory A. Cote

Lead Sponsor

Trials

1

Recruited

180+

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6699897/

SpHincterotomy for Acute Recurrent Pancreatitis Randomized ... There are limited preliminary data supporting the use of endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla endoscopic sphincterotomy ( ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03609944

SpHincterotomy for Acute Recurrent Pancreatitis (SHARP) The purpose of this study is to determine if a procedure called Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincterotomy reduces the risk ...

3. e-ce.org e-ce.org/journal/view.php?number=7321

Determining the Optimal Subgroup of Patients in Whom ... At the index ERCP of RAP patients without pancreatic duct dilatation, 45.9% of endoscopists might perform biliary sphincterotomy. However, the ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1091255X23062145

ERCP and Endoscopic Sphincterotomy (ES): A Safe and ... Eighty-nine patients were successfully treated with an ERCP alone, and 84 patients (94%) had no recurrence of pancreatitis with a mean follow-up of 41 months (± ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10925971/

Idiopathic recurrent pancreatitis: long-term results after ... Conclusions: Diagnostic and therapeutic ERCP and UDCA were effective in 92.5% of our cases, over a long follow-up, indicating that the term "idiopathic" was ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7433733/

Evaluation of Safety and Outcomes of Endoscopic ... They reported that early complications occurred in 7.8% and late complications developed in 10 out of 110 patients. They concluded that ERCP is safe and ...

7. academic.oup.com academic.oup.com/jcag/article/8/Supplement_2/S74/8029082

Role of endoscopic retrograde cholangiopancreatography in ... This paper looks at how ERCP is used to treat conditions such as acute gallstone pancreatitis, pancreas divisum (PD), sphincter of Oddi dysfunction (SOD), and ...