Chemo cocktail aimed at zapping pancreatic cysts
NCT ID NCT03085004
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether injecting chemotherapy drugs directly into pancreatic cysts could shrink or eliminate them. It involved 75 adults with cysts between 2-5 cm. The approach used an endoscope to guide the injection, comparing two different pre-treatment rinses. The trial was stopped early, so results are limited.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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75 people
The number who actually took part.
- Started
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Apr 2019
- Finished
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Feb 2026
- 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: * Adult subjects over the age of 18. * Patients with a previously-detected pancreatic cyst(s) 2-5 cm in diameter which is consistent with a mucinous type cyst as per ASGE guidelines, including indeterminate type cysts. * Able to give written informed consent. * Capable of safely undergoing endoscopy with deep sedation or general anesthesia. Exclusion Criteria: * Lesions which are consistent with a benign cyst by clinical, cytological, chemical, and radiographic evaluation as per ASGE guidelines (i.e., consistent with a pseudocyst or serous cystadenoma). * Known or suspected pancreatic cancer or pathologic lymphadenopathy. * Cysts with the following high-risk features: main pancreatic duct dilation of \> 5mm, epithelial type mural nodules (\> 2mm)33, pathologically thick wall/septation (\> 2mm), cytology showing high grade dysplasia or "suspicious for malignancy", signs of common bile duct or pancreatic duct obstruction, solid mass component within or associated with the cyst (\> 2mm), pancreatic duct stricture associated with tail atrophy, or previous fine needle aspiration failure due to excessive cyst fluid viscosity. (Of note, the following higher-risk features ARE eligible: recent growth in size, atypical cells on cytology, and symptoms referable to the pancreas.) * Septated cysts with \> 4 compartments. * Confirmed acute pancreatitis within the last 6 months. * Baseline lab values (must be within 6 months of consent date) in the following ranges: white blood cells \> 14 or \< 2 K/uL, hematocrit \<30%, platelets \<30 K/uL, non-pharmacologic INR \>1.7, CA19-9 \>2x ULN, lipase \>2x ULN, creatinine \>3.0 mg/dl (unless stable on renal replacement therapy), ALT \>500 U/L, total bilirubin \>2.5 mg/dl. * Any pre-existing or discovered medical condition that would, at the discretion of the investigator, interfere with the completion of and/or participation in the existing protocol. This includes severe pre-existing medical conditions which would preclude a reasonable 5 year life expectancy (and thus neutralize the patient's benefit from ablating a premalignant type pancreatic cyst). * Pregnancy, breastfeeding, or incarcerated individual.
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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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Indiana University Health University Hospital
Indianapolis, Indiana, 46202, United States
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Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
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Other studies related to the condition(s) this trial covers.
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