SpHincterotomy for Acute Recurrent Pancreatitis

Pancreatitis Clinical Trial

— SHARP  

Official title:

SpHincterotomy for Acute Recurrent Pancreatitis (SHARP Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03609944
• Other study ID #: 1922
• Secondary ID: U01DK116743
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2018
• Est. completion date: September 1, 2027

Study information

• Verified date: November 2023
• Source: Oregon Health and Science University
• Contact: Gregory Cote, MD, MS
• Phone: 503-494-5255
• Email: coteg[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: September 1, 2027
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreas Divisum
• Pancreas Inflamed
• Pancreatitis
• Pancreatitis Idiopathic
• Pancreatitis, Acute
• Pancreatitis, Chronic

Intervention

Procedure:
• ERCP with miES
Endoscopic retrograde cholangiopancreatography with minor papilla endoscopic sphincterotomy
• EUS
Endoscopic ultrasound

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Winnipeg	Manitoba
Netherlands	Radboud University Medical Center	Nijmegen
United States	Emory University Hospital	Atlanta	Georgia
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	The Ohio State University - Wexner Medical Center	Columbus	Ohio
United States	Methodist Dallas Medical Center	Dallas	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Saint Luke's Hospital System	Kansas City	Missouri
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Cedars-Sinai	Los Angeles	California
United States	Keck Hospital of USC	Los Angeles	California
United States	University of Minnesota	Minneapolis	Minnesota
United States	Yale School of Medicine	New Haven	Connecticut
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	University of Rochester	Rochester	New York
United States	UCSF Medical Center	San Francisco	California
United States	Virginia Mason Hospital & Seattle Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Countries where clinical trial is conducted

United States,  Canada,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduce the risk of subsequent acute pancreatitis episodes by 33%	To test this aim, compare the incidence of acute pancreatitis > 30 days after treatment allocation as the primary outcome measure, using the next attack of acute pancreatitis as a time-to-event outcome.	This is a time-to-event outcome that is assessed starting 30 days after treatment through a maximum follow-up of 48 months.
Secondary	To compare the incidence rate ratio of acute pancreatitis between treatment groups	All randomized subjects will be followed longitudinally until study completion (minimum follow-up of six months, maximum follow-up of 48 months), even if acute pancreatitis occurs during follow-up. A secondary benefit of miES may be a reduction in acute pancreatitis frequency, defined as the incidence rate (episodes/time pre- and post-randomization). Since baseline incidence rate is a probable predictor of post-randomization incidence rate, the investigators will compare the incidence rate ratios between the two arms, keeping person-time equal between the pre/post periods.	Incidence rate will be assessed starting 30 days after treatment through a maximum follow-up of 48 months.

External Links

•   study trial website