SpHincterotomy for Acute Recurrent Pancreatitis

NCT03609944 | Completed Results DMC

• 2 other identifiers: 1922U01DK116743
• Study Type: interventional
• Target: 181
• Locations: 2 countries
• Sites: 21

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.

Conditions

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

Keywords

ERCP; Endoscopic retrograde cholangiopancreatography; pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To Compare the Incidence Rate Ratio of Acute Pancreatitis Between Treatment Groups

  Incidence rate will be assessed starting 30 days after treatment through a maximum follow-up of 48 months.

Study Arms (2)

EUS + Sham

SHAM COMPARATOR

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.

Procedure: EUS

EUS + ERCP with miES

EXPERIMENTAL

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.

Procedure: ERCP with miES; Procedure: EUS

Interventions

EUS PROCEDURE

Endoscopic ultrasound

EUS + ERCP with miES; EUS + Sham

ERCP with miES PROCEDURE

Endoscopic retrograde cholangiopancreatography with minor papilla endoscopic sphincterotomy

EUS + ERCP with miES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must consent to be in the study and must have signed and dated an approved consent form.
• \>18 years
• 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
• At least one episode of acute pancreatitis within 24 months of enrollment
• Pancreas divisum confirmed by prior MRCP that is reviewed by an abdominal radiologist at the recruiting site.
• By physician assessment, there is no certain explanation for recurrent acute pancreatitis.
• 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

You may not qualify if:

• Prior minor papilla therapy (endoscopic or surgical)
• 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.
• Main pancreatic duct stricture\*
• Presence of a structural etiology for acute pancreatitis, such as anomalous pancreatobiliary union, periampullary mass, or pancreatic mass lesion on imaging\*
• Presence of a local complication from acute pancreatitis which requires pancreatogram
• Regular use of opioid medication for abdominal pain for the past three months
• Medication as the etiology for acute pancreatitis by physician assessment
• TWEAK score ≥ 4

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Oregon Health and Science University: lead

Study Sites (21)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

Cedars-Sinai

Los Angeles, California, 90048, United States

Location

UCSF Medical Center

San Francisco, California, 94143, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Saint Luke's Hospital System

Kansas City, Missouri, 64111, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

University of Rochester

Rochester, New York, 14627, United States

Location

The Ohio State University - Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Oregon Health and Science University

Portland, Oregon, 97202, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29407, United States

Location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Virginia Mason Hospital & Seattle Medical Center

Seattle, Washington, 98101, United States

Location

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Related Publications (3)

• 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.

  PMID: 31404020 BACKGROUND

• 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.

  PMID: 36585282 BACKGROUND

• Cote GA, Durkalski-Mauldin V, Fogel EL, Moffatt DC, Wang AY, Lara LF, Tarnasky PR, Buxbaum JL, Dai SC, Jonnalagadda S, Willingham FF, Ross A, Keswani RN, Inamdar S, Kothari TH, Gardner TB, Jamidar PA, Gaddam S, Pleskow DK, Easler JJ, Elmunzer BJ, Coneys JG, Mallery JS, Strand DS, Papachristou GI, Slivka A, Kedia P, Sahakian AB, Kouanda A, Phan A, Williams A, Andersen DK, Serrano J, Yadav D; SHARP Consortium. Minor Papillotomy for Treatment of Idiopathic Acute Pancreatitis With Pancreas Divisum: A Randomized Clinical Trial. JAMA. 2026 Feb 24;335(8):682-692. doi: 10.1001/jama.2025.23988.

  PMID: 41533371 DERIVED

MeSH Terms

Conditions

Pancreatitis; Pancreas Divisum

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Gregory Cote
• Organization: Oregon Health and Science University

coteg@ohsu.edu

503-494-4373

Study Officials

• Gregory A Cote, MD, MS

  Oregon Health and Science University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In addition to the participant and the investigator assessing outcomes, study coordinators involved in collecting outcomes data will be masked to the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Subjects will be randomized 1:1 to either EUS+sham or EUS+ERCP with miES.

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 1, 2018
• Study Start: September 27, 2018
• Primary Completion: February 28, 2025
• Study Completion: August 31, 2025
• Last Updated: December 30, 2025
• Results First Posted: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (20); CA (1)