New procedure could zap pancreatic cysts before they turn deadly
NCT ID NCT05961982
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a less invasive procedure called endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) to treat pancreatic cysts that have a high risk of turning into cancer. About 84 adults with pancreatic cysts at least 2 cm in size and showing concerning features will receive this treatment. The goal is to shrink the cysts by at least half and reduce the need for risky surgery or frequent monitoring.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 84 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- 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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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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: * Age \> 18 years * A diagnosis of a PCN confirmed by EUS-FNA including cyst fluid next generation sequencing (NGS) and/or EUS-guided needle-based confocal laser endomicroscopy (nCLE) and/or EUS- guided through-the-needle biopsy (TTNB) * The pancreatic cystic lesion (PCL) measures at least 2 cm in diameter on either CT or MRI/MRCP or EUS and demonstrates concerning worrisome and/or high-risk features as defined by International Consensus Guidelines (2017 revised Fukuoka Guidelines) * The patient is not a surgical candidate. Common clinical scenarios include - * Cirrhosis of the liver (common clinical scenario) * Advanced ( \>= 75 years) age (common clinical scenario) * Morbid obesity * Significant cardiorespiratory comorbidity * Patient's choice (patient elects for non-surgical management) * Other significant comorbid conditions that impose prohibitive surgical risks * Estimated life expectancy of at least 1 year * Capable of giving written informed consent or has a legally authorized representative (LAR) to consent for them * Women of childbearing potential must have a negative pregnancy test (serum/urine) on the day of treatment. Pregnancy testing is the routine standard of care practice in the endoscopy laboratory for all patients undergoing endoscopy and sedation for endoscopy * The patient prefers non-surgical management after consultation with hepato-pancreato-biliary (HPB) surgery * The patient is not a surgical candidate and has had prior attempts at ablation of the PCN by EUS-guided injection of chemotherapy (Ohio State University \[OSU\] Institutional Review Board \[IRB\] protocol 2020C0198) Exclusion Criteria: * A diagnosis of a benign or non-neoplastic PCL such as a pseudocyst confirmed by EUS-FNA including cyst fluid NGS and/or EUS-nCLE and/or EUS-TTNB * A diagnosis of a malignant PCN confirmed by evidence of adenocarcinoma and/or invasive carcinoma and/or distant metastases * Cysts or neuroendocrine tumors (NETS) involving or in close proximity to blood vessels, the biliary tree, or the main pancreatic duct where the zone of ablation is likely to compromise these structures * Acute pancreatitis in the preceding 4 weeks prior to date of EUS-RFA * Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it unsafe for the patient to participate in the study * Any psychiatric disorder making reliable informed consent impossible * Pregnancy or breast-feeding * Eastern Cooperative Oncology Group (ECOG) performance status 4 * Contraindication to general anesthesia after review by OSU Preoperative Assessment Clinic (OPAC) * Cardiac implantable electrical devices
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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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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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
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A doctor treating you
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Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Ohio State University Comprehensive Cancer Center
RECRUITINGColumbus, Ohio, 43210, United States
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Other studies related to the condition(s) this trial covers.
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