Hope for pancreatic cancer prevention: old drug, new trial
NCT ID NCT04207944
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This study tests whether the anti-inflammatory drug sulindac can prevent high-risk pancreatic cysts (IPMNs) from progressing to pancreatic cancer. About 100 adults with these cysts will receive either sulindac or a placebo for up to 3 years, alongside standard monitoring. The goal is to see if the drug reduces cyst growth, new cysts, or cancer development.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2020
- Expected to finish
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Oct 2026
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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21 to 85 years
- 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. Subject is a man or woman between the ages of 21 and 85 (inclusive) years. 2. Subject has high-risk IPMN as defined below. 1. Patient (previously resected) has undergone partial pancreatectomy for non-invasive IPMN AND has new or residual cyst(s) \> 1 cm and/or 2. Patient (not previously resected) has a radiographic lesion of the pancreas consistent with IPMN as documented by: Cyst fluid CEA \> 192 ng/ml OR presence of GNAS or RNF 43 mutation noted in cyst fluid OR MRI imaging confirmation of "likely", "probable" or "confirmed" communication with main pancreatic duct AND at least one of the following worrisome features: * Cyst \> 2.5 cm * Thickened/enhancing cyst walls * Main pancreatic duct \> 5mm * Abrupt change in caliber of pancreatic duct with distal atrophy 3. Subjects has ECOG of 0-2 4. Subject is medically fit to undergo EUS. 5. Female subjects who are of childbearing potential or are capable of becoming pregnant must be willing to use appropriate methods of contraception for the length of the study. 6. Subject is able to provide written informed consent. Exclusion Criteria: 1. Subject has pathologic evidence of pancreatic adenocarcinoma. 2. Subject takes a systemic corticosteroid or NSAID more than 3 times per week. 3. Subject has a known history of or currently existing allergy to NSAIDs, aspirin induced asthma, gastric ulcers, non-iatrogenic intestinal perforation, or gastrointestinal bleeding from NSAID usage for which intervention was required.. 4. Subject has an ongoing history of renal insufficiency (eGFR \<50 mL/minute/1.73 m2), cardiovascular disease, gastrointestinal disorder, or any other condition that serves as a contraindication to the use of sulindac in the opinion of the treating investigator. 5. Myocardial infarction or coronary artery bypass grafting within six months of study entry. 6. Diagnosis of Congestive Heart Failure. 7. Severe adverse drug reaction to contrast agents that cannot be managed with routine premedication prior to imaging. 8. Diagnosis for (other) prior malignancy (except in situ and non-melanoma skin cancers) and are actively receiving antineoplastic or immuno therapy within 90 days of randomization. 9. History of medical procedure that would prevent an endoscopic ultrasound from being performed (such as Roux-en-Y, prior total gastrectomy). 10. Subject is lactating or pregnant.
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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.
Contacts and locations
Locations
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Duke University Medical Center
Durham, North Carolina, 27710, United States
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Johns Hopkins University
Baltimore, Maryland, 21287, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Memorial Sloan Kettering
New York, New York, 10021, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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