Endoscopic ultrasound-guided radiofrequency ablation for pancreatic tumors
Endoscopic Ultrasound-Guided Radiofrequency Ablation of Pancreatic Cysts - A Safety and Efficacy Trial (ERASE Study)
This study is testing a new, less invasive treatment using ultrasound and heat to see if it can safely help people with pancreatic tumors, especially cystic neoplasms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT05961982 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with pancreatic cystic neoplasms that are not suitable for surgical intervention due to various health conditions.
Not a fit: Patients with surgically resectable pancreatic tumors or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive option for managing pancreatic tumors, potentially improving patient outcomes and survival rates.
How similar studies have performed: Other studies have shown promise with radiofrequency ablation for treating pancreatic tumors, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Columbus, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.