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Procedure
Sphincterotomy for Acute Recurrent Pancreatitis (SHARP Trial)
N/A
Recruiting
Research Sponsored by Gregory A. Cote
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pancreas divisum confirmed by prior MRCP that is reviewed by an abdominal radiologist at the recruiting site
Age >18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this is a time-to-event outcome that is assessed starting 30 days after treatment through a maximum follow-up of 48 months.
Awards & highlights
SHARP Trial Summary
This trial is testing whether a procedure called ERCP with sphincterotomy reduces the risk of pancreatitis or the number of recurrent pancreatitis episodes in patients with pancreas divisum.
Who is the study for?
This trial is for adults over 18 who've had at least two episodes of acute pancreatitis within the last 24 months, confirmed pancreas divisum, and no clear cause for their condition. They must be able to participate fully in the study and have not undergone any prior minor papilla therapy or regularly used opioids for abdominal pain.Check my eligibility
What is being tested?
The study tests if ERCP with sphincterotomy can reduce pancreatitis risk or recurrence in patients with pancreas divisum. Participants are randomly assigned to receive either the actual procedure or a sham (fake) procedure, followed up at intervals until a maximum of 48 months.See study design
What are the potential side effects?
Potential side effects from ERCP with sphincterotomy may include discomfort, infection, bleeding, inflammation of the pancreas (pancreatitis), and rarely more serious complications like perforation.
SHARP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My pancreas divisum was confirmed by an MRCP reviewed by a specialist.
Select...
I am older than 18 years.
SHARP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ incidence rate will be assessed starting 30 days after treatment through a maximum follow-up of 48 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~incidence rate will be assessed starting 30 days after treatment through a maximum follow-up of 48 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduce the risk of subsequent acute pancreatitis episodes by 33%
Secondary outcome measures
To compare the incidence rate ratio of acute pancreatitis between treatment groups
SHARP Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EUS + ERCP with miESExperimental Treatment2 Interventions
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 II: EUS + ShamPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EUS
2008
Completed Phase 4
~460
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,315,007 Total Patients Enrolled
26 Trials studying Pancreatitis
31,287 Patients Enrolled for Pancreatitis
Gregory A. CoteLead Sponsor
Oregon Health and Science UniversityLead Sponsor
973 Previous Clinical Trials
6,845,795 Total Patients Enrolled
2 Trials studying Pancreatitis
26 Patients Enrolled for Pancreatitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had an acute pancreatitis episode in the last 2 years.My pancreas divisum was confirmed by an MRCP reviewed by a specialist.I have had at least two acute pancreatitis attacks confirmed by pain, high enzyme levels, or imaging.My acute pancreatitis is caused by a structural issue seen in imaging tests.I have a narrowed main pancreatic duct.I need a special scan for a pancreas problem caused by inflammation.I can understand and participate in all study requirements.I have had previous minor papilla therapy.Your TWEAK score is 4 or higher.I have been using opioid painkillers for abdominal pain for the last three months.My doctor thinks my pancreatitis was caused by medication.I am older than 18 years.My doctor can't explain why I keep getting acute pancreatitis.
Research Study Groups:
This trial has the following groups:- Group 1: EUS + Sham
- Group 2: EUS + ERCP with miES
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many medical sites are executing this experimental trial?
"Presently, this research study is recruiting participants from 22 sites distributed across the United States. Notable cities with trial centres include Dallas, Rochester and Los Angeles; it may be convenient to choose a clinic in your vicinity to reduce travel burdens if you enroll."
Answered by AI
Is this research project actively seeking participants?
"As indicated by clinicaltrials.gov, the recruitment phase for this medical experiment is currently underway; it was initially started on September 27th 2018 and most recently revised July 29th 2022."
Answered by AI
How many participants are actively engaged in this experiment?
"For the clinical trial to be successful, 234 qualified individuals must partake in it. The sites hosting this research include Methodist Dallas Medical Center (Dallas, TX) and University of Rochester(Rochester, NY)."
Answered by AI
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