SpHincterotomy for Acute Recurrent Pancreatitis

NCT ID: NCT03609944

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 181 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-27
• Study Completion Date: 2025-08-31

Brief 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.

Detailed 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).

Conditions

Pancreatitis; Pancreas Divisum; Pancreatitis, Acute; Pancreatitis Idiopathic; Pancreas Inflamed

Keywords

ERCP; Endoscopic retrograde cholangiopancreatography; pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

EUS + Sham

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.

Group Type: SHAM_COMPARATOR

EUS

Intervention Type: PROCEDURE

Endoscopic ultrasound

EUS + ERCP with miES

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 Type: EXPERIMENTAL

ERCP with miES

Intervention Type: PROCEDURE

Endoscopic retrograde cholangiopancreatography with minor papilla endoscopic sphincterotomy

EUS

Intervention Type: PROCEDURE

Endoscopic ultrasound

Interventions

ERCP with miES

Endoscopic retrograde cholangiopancreatography with minor papilla endoscopic sphincterotomy

Intervention Type: PROCEDURE

EUS

Endoscopic ultrasound

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Gregory Cote

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gregory A Cote, MD, MS

Role: STUDY_CHAIR

Oregon Health and Science University

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Keck Hospital of USC

Los Angeles, California, United States

Cedars-Sinai

Los Angeles, California, United States

UCSF Medical Center

San Francisco, California, United States

Yale School of Medicine

New Haven, Connecticut, United States

Emory University Hospital

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Saint Luke's Hospital System

Kansas City, Missouri, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

University of Rochester

Rochester, New York, United States

The Ohio State University - Wexner Medical Center

Columbus, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Methodist Dallas Medical Center

Dallas, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Virginia Mason Hospital & Seattle Medical Center

Seattle, Washington, United States

Health Sciences Centre

Winnipeg, Manitoba, Canada

Countries

Netherlands; United States; Canada

References

Cote GA, Durkalski-Mauldin VL, Serrano J, Klintworth E, Williams AW, Cruz-Monserrate Z, Arain M, Buxbaum JL, Conwell DL, Fogel EL, Freeman ML, Gardner TB, van Geenen E, Groce JR, Jonnalagadda SS, Keswani RN, Menon S, Moffatt DC, Papachristou GI, Ross A, Tarnasky PR, Wang AY, Wilcox CM, Hamilton F, Yadav D; SHARP Consortium. SpHincterotomy for Acute Recurrent Pancreatitis Randomized Trial: Rationale, Methodology, and Potential Implications. Pancreas. 2019 Sep;48(8):1061-1067. doi: 10.1097/MPA.0000000000001370.

Reference Type: BACKGROUND

PMID: 31404020 (View on PubMed)

Cote GA, Durkalski-Mauldin V, Williams A, Nitchie H, Serrano J, Yadav D; SHARP Consortium. Design and execution of sham-controlled endoscopic trials in acute pancreatitis: Lessons learned from the SHARP trial. Pancreatology. 2023 Mar;23(2):187-191. doi: 10.1016/j.pan.2022.12.011. Epub 2022 Dec 21.

Reference Type: BACKGROUND

PMID: 36585282 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

U01DK116743

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1922

Identifier Type: -

Identifier Source: org_study_id