Trial · Interventional

CompletedNot applicableResults postedRegistry data

SpHincterotomy for Acute Recurrent Pancreatitis

Short name SHARP

NCTNCT03609944Other id1922Other idU01DK116743

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Names Methylene blue, does not test it. It appears in the description.

Overview

Status: Completed
Phase: Not applicable
Enrollment: 181 participants (actual)
Sponsor: Oregon Health and Science University · Other
Design: Randomized · Double masking
Countries: 2 countries
United States, Canada
Start: 27 Sept 2018
Primary completion: 28 Feb 2025
Completion: 31 Aug 2025
First posted: 1 Aug 2018
Last update posted: 30 Dec 2025
Conditions: Pancreatitis · Pancreas Divisum · Pancreatitis, Acute · Pancreatitis Idiopathic · Pancreas Inflamed

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20182020202220242026

N/A
SHARP
NCT03609944
27 Sept 2018 to 31 Aug 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

ERCP with miESProcedure
EUSProcedure

Arms2

Sham comparator
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.
Experimental
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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.
Registry description
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.

Secondary outcomes(1)

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.
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· This is a time-to-event outcome that is assessed starting 30 days after treatment through a maximum follow-up of 48 months.

Reduce the Risk of Subsequent Acute Pancreatitis Episodes by 33%

Group	Value (Participants)
EUS + Sham	32
EUS + ERCP with miES	26

Secondary and other outcome results(1)

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

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

Group	Value (Incidence rate ratio)
EUS + Sham	0.304
EUS + ERCP with miES	.246

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
EUS + ShamSubjects 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: Endoscopic ultrasound	3 / 73	48 / 73	8 / 73
EUS + ERCP With miESSubjects 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. ERCP with miES: Endoscopic retrograde cholangiopancreatography with minor papilla endoscopic sphincterotomy EUS: Endoscopic ultrasound	2 / 75	48 / 75	15 / 75

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedCote 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

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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