Can clearing a blocked pancreatic duct restore insulin production?
NCT ID NCT07810309
First seen Sep 09, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
Researchers at Mayo Clinic are running a pilot study to see whether clearing a blocked pancreatic duct improves how the pancreas makes insulin in people with chronic pancreatitis. Participants are adults with minimally symptomatic chronic pancreatitis and a duct blockage. The study randomly assigns them to receive an endoscopic procedure that clears the blockage or to not have the procedure, then measures insulin secretion over six months. The main goal is to find out whether a larger trial is feasible.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- endoscopic pancreatic duct decompression, a procedure that uses an endoscope to clear pancreatic duct blockages
- What this could lead to
- If the approach works, it could show that relieving a pancreatic duct blockage helps the pancreas make insulin, which might guide future treatment for chronic pancreatitis.
- What could go wrong
- This is a small pilot study with 30 people, so it may not produce clear answers or generalise to all patients. Endoscopic procedures carry risks such as pancreatitis, bleeding, or infection.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged ≥ 18 4. Chronic pancreatitis as defined by Cambridge grade 3 or 4 (3: \> 3 abnormal side branches; 4: abnormal main duct and branches) pancreatic ductal changes and/or parenchymal and/or intraductal calcifications (chronic calcific pancreatitis) by CT Scan or MRI/MRCP24 5. Minimally symptomatic: * Asymptomatic patients who were incidentally diagnosed with chronic pancreatitis based on imaging * Mild to moderate pain (visual analog scale ≤ 5) who do not require daily opioid pain medications * ≤ 1 episode of uncomplicated acute pancreatitis in 12 months prior to enrollment Exclusion Criteria: 1. History of diabetes (defined as either a HbA1c ≥ 6.5 % or a fasting glucose ≥ 126 mg/dL) 2. Pancreatic duct obstruction limited to the tail of pancreas 3. Surgically altered forgot anatomy prohibitive of ERCP with standard techniques (e.g Billroth II, Roux-en-y gastric bypass, pancreaticoduodenectomy) 4. Prior pancreatic surgery 5. Pancreatic head mass or suspicion for pancreatic malignancy 6. Concurrent extra-pancreatic malignancy other than non-melanoma skin cancer 7. Prior endoscopic therapy for pancreatic duct obstruction 8. Acute pancreatitis \< 90 days prior to enrollment 9. Active alcohol use within 2 months of enrollment 10. Gastrointestinal stricture/obstruction precluding passage of the duodenoscope to the papilla 11. Standard contraindications to ERCP 12. Unable to receive general anesthesia
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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