Endoscopic ultrasound-guided radiofrequency ablation for pancreatic tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) for managing pancreatic tumors, particularly cystic neoplasms. Patients will undergo standard care procedures, including fine-needle aspiration, followed by EUS-RFA, with follow-up assessments using imaging techniques. The study aims to determine both the efficacy and safety of this minimally invasive treatment approach, with long-term monitoring for tumor response over a period of up to three years.

Why it matters

Who can join: the full rules

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

Where it's running

• Ohio State University Comprehensive Cancer Center
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Somashekar G Krishna, MD — 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

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.