Endoscopic chemoablation for pancreatic cysts
Official title: Endoscopic Ultrasound-Guided Chemoablation of Pancreatic Cysts - An Efficacy Trial
Run by Ohio State University Comprehensive Cancer Center · NCT07529483 · Data updated 2026-11-12
This phase 2 trial tests whether injecting chemotherapy into pancreatic cysts using an endoscope can help treat these precancerous lesions in adults who aren’t surgical candidates.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Columbus, Ohio) |
| Status | Recruiting |
| Started | May 12, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | May 29, 2026 |
| Trial ID | NCT07529483 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with diagnosed pancreatic cystic neoplasms measuring 1 cm or larger who are not surgical candidates and have had prior ablation or are considered non-resectable.
✕Probably not a fit
Patients whose cysts do not respond to intracystic chemotherapy or who experience adverse effects may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the safety and efficacy of endoscopic ultrasound-guided chemoablation for pancreatic cystic neoplasms. Participants receive intracystic injections of gemcitabine and paclitaxel after an EUS-guided fine needle aspiration. The trial includes imaging, cyst fluid analysis, and serial follow-up as part of standard care for up to three years. Outcomes focus on how well the cysts respond and whether the procedure is safe. Eligible individuals are adults with cysts of at least 1 cm who are not surgical candidates.
Why it matters
Potential benefit: If successful, patients may experience reduced cyst burden and a lower risk of progression to pancreatic cancer without surgery.
How similar studies have gone: Previous endoscopic ablation approaches have shown some promise, but this exact chemoablation strategy is being tested for the first time in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * A diagnosis of a pancreatic cystic neoplasm (PCN) confirmed by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) including cyst fluid next-generation sequencing (NGS) and/or EUS-needle based confocal laser endomicroscopy (nCLE) and/or EUS-through the needle biopsy (TTNB) * The pancreatic cystic lesion (PCL) measures at least 1 cm in diameter on CT, MRI/MRCP, or EUS * This cohort may include patients with PCNs previously treated with other ablative modalities include EUS-radiofrequency ablation (RFA) (NCT05961982, institutional review board \[IRB\]: 2023C0004) or EUS-pulsed electric field (PEF) (IRB 20251089) who have shown either no response or only a partial response to therapy * 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 Exclusion Criteria: * 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 * Pregnant patients will be excluded due to confounding variables * Contraindication to general anesthesia after review by Ohio State University (OSU) Preoperative Assessment Clinic (OPAC) * Non-English speaking individuals are excluded because study materials, consent forms, and validated patient-reported assessments are available only in English, and interpreter-mediated consent could compromise comprehension of procedural risks associated with an investigational intervention
Where it's running
-
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States Recruiting
Study contacts
- Principal investigator: Somashekar G Krishna, MD, MPH — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.