Can a double dose stop Post-Procedure pancreatitis?
NCT ID NCT07247682
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two doses of a rectal anti-inflammatory drug (indomethacin) to prevent pancreatitis after an ERCP procedure in people at high risk. About 1,036 adults will be randomly assigned to receive either 100 mg or 200 mg right after the procedure. The goal is to see if the higher dose reduces the number and severity of pancreatitis cases.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 1,036 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria:Participants will be eligible for enrollment if they meet all of the following criteria: 1. age over 18 years; 2. classified as high risk for post-ERCP pancreatitis; 3. provision of signed, written informed consent. Exclusion Criteria:Participants will be excluded if they meet any of the following conditions: 1. inaccessible major papilla; 2. surgically altered gastrointestinal anatomy; 3. current diagnosis of acute pancreatitis; 4. placement of a pancreatic stent; 5. contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs), including known allergy, renal insufficiency, or active peptic ulcer disease; 6. anticipated low risk of post-ERCP pancreatitis (e.g., patients with chronic calcific pancreatitis, pancreatic head mass, or those undergoing biliary interventions through a pre-existing sphincterotomy); 7.severe active cardiopulmonary disease; 8. pregnancy or breastfeeding; 9. presence of an ampullary tumor. \-
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- One-Time drug infusion may shield the pancreas after ERCP
- A 4-Hour IV drip could stop a common Post-ERCP complication
- Could a simple ice water flush prevent pancreatitis after a common procedure?
- Common painkiller may prevent pancreatitis after bile duct procedure
- Can a simple pill prevent pancreatitis after ERCP? new study tests two drugs
- When to remove pancreatic stents? new trial aims to find out