PancreatitisSHARPNCT03609944
SpHincterotomy for Acute Recurrent Pancreatitis
A study testing ERCP with miES and EUS in people with Pancreatitis and Pancreas Divisum, run by Oregon Health and Science University at 21 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis, Pancreas Divisum, Pancreatitis, Acute
- What is being tested?
- ERCP with miES and EUS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 27 Sep 2018to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States20 sites
Emory University Hospital
Atlanta, Georgia, 30322
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29407
University of Virginia
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
The Ohio State University - Wexner Medical Center
Columbus, Ohio, 43210
Methodist Dallas Medical Center
Dallas, Texas, 75203
Indiana University
Indianapolis, Indiana, 46202
Saint Luke's Hospital System
Kansas City, Missouri, 64111
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Keck Hospital of USC
Los Angeles, California, 90033
Cedars-Sinai
Los Angeles, California, 90048
University of Minnesota
Minneapolis, Minnesota, 55455
Yale School of Medicine
New Haven, Connecticut, 06520
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Oregon Health and Science University
Portland, Oregon, 97202
University of Rochester
Rochester, New York, 14627
UCSF Medical Center
San Francisco, California, 94143
Virginia Mason Hospital & Seattle Medical Center
Seattle, Washington, 98101
About this study
Official title: SpHincterotomy for Acute Recurrent Pancreatitis (SHARP Trial)
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.
Read the 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
- Being tested
- ERCP with miES, EUS
- Keywords
- ERCP, Endoscopic retrograde cholangiopancreatography, pancreatitis
- Medical subject headings
- Pancreatitis, Pancreas Divisum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP with miESProcedure or surgery
Endoscopic retrograde cholangiopancreatography with minor papilla endoscopic sphincterotomy
EUSProcedure or surgery
Endoscopic ultrasound
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: ERCP with miES; Procedure: EUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Incidence rate will be assessed starting 30 days after treatment through a maximum follow-up of 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start27 Sep 2018
- Primary completion28 Feb 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized 1:1 to either EUS+sham or EUS+ERCP with miES.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Cote, Oregon Health and Science University
- Investigators
- Gregory A Cote, MD, MS, Study chair, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609944
- Sponsor's protocol ID
- 1922
- Other IDs
- U01DK116743
- Acronym
- SHARP
- Status last verified
- Dec 2025
- First submitted
- 24 Jul 2018
- Last updated
- 30 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31404020Cote 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.
PubMed 36585282Cote 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.
PubMed 41533371
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpHincterotomy for Acute Recurrent Pancreatitis (SHARP Trial)
- ClinicalTrials.gov ID
- NCT03609944
- Acronym / sponsor ID
- SHARP / 1922
- Conditions
- Pancreatitis, Pancreas Divisum, Pancreatitis, Acute, Pancreatitis Idiopathic, Pancreas Inflamed
- Keywords
- ERCP, Endoscopic retrograde cholangiopancreatography, pancreatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Posted 30 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized 1:1 to either EUS+sham or EUS+ERCP with miES.
| Arm | Type | Receives |
|---|---|---|
| EUS + Sham | Sham comparator | Procedure: EUSSubjects 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. |
| EUS + ERCP with miES | Experimental | Procedure: ERCP with miES, Procedure: EUSSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERCP with miESEndoscopic retrograde cholangiopancreatography with minor papilla endoscopic sphincterotomy | Procedure or surgery | EUS + ERCP with miES |
| EUSEndoscopic ultrasound | Procedure or surgery | EUS + ERCP with miES, EUS + Sham |
Primary outcome
Reduce the Risk of Subsequent Acute Pancreatitis Episodes by 33%
Time frame: This is a time-to-event outcome that is assessed starting 30 days after treatment through a maximum follow-up of 48 months.
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.
1 secondary outcome
To Compare the Incidence Rate Ratio of Acute Pancreatitis Between Treatment Groups
Time frame: Incidence rate will be assessed starting 30 days after treatment through a maximum follow-up of 48 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31404020Cote 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.
- Background: PubMed 36585282Cote 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.
- Derived from this study: PubMed 41533371Cote 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory A Cote, MD, MS study chair
Oregon Health and Science University
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERCP with miES and EUS in people with Pancreatitis and Pancreas Divisum, run by Oregon Health and Science University at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduce the Risk of Subsequent Acute Pancreatitis Episodes by 33% (time frame: This is a time-to-event outcome that is assessed starting 30 days after treatment through a maximum follow-up of 48 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03609944, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.