Actively Recruiting
Endoscopic Ultrasound-Guided Radiofrequency Ablation of Pancreatic Cysts - A Safety and Efficacy Trial (ERASE Study)
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-03-23
84
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) to treat pancreatic tumors, including cysts, which can progress to pancreatic cancer. Pancreatic cancer is often fatal and hard to detect early, with a low five-year survival rate. This trial focuses on patients with high-risk pancreatic cysts who are not candidates for surgery, aiming to offer a less invasive treatment option that may reduce the need for frequent monitoring and delay or prevent cancer progression. Participants receive standard endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) followed by the EUS-RFA procedure. Some may have repeat EUS-RFA or EUS-guided chemoablation during follow-up surveillance. Imaging tests such as MRI, MRCP, CT scans, or additional EUS-FNA are performed at the start and during follow-up visits to monitor the cysts and treatment effects. During the study, participants are followed every 3 to 6 months for cysts 3 cm or larger, or every 6 to 12 months for smaller cysts, up to three years. Researchers evaluate the treatment's effectiveness at one year and monitor long-term response and safety up to three years after EUS-RFA. Safety is assessed immediately after the procedure and at one year, with ongoing imaging and clinical assessments throughout the follow-up period.
CONDITIONS
Brief Title
Evaluation of Endoscopic Ultrasound-Guided Radiofrequency Ablation for the Management of Pancreatic Tumors, ERASE Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Diagnosed pancreatic cystic neoplasm confirmed by EUS-FNA including cyst fluid sequencing, confocal laser endomicroscopy, or through-the-needle biopsy
- Pancreatic cystic lesion measuring at least 2 cm on CT, MRI/MRCP, or EUS with concerning high-risk features per 2017 Fukuoka Guidelines
- Patient is not a surgical candidate due to factors such as cirrhosis, advanced age (75 years or older), morbid obesity, significant heart or lung conditions, personal choice, or other major comorbidities
- Estimated life expectancy of at least 1 year
- Ability to provide written informed consent or have a legally authorized representative consent
- Women of childbearing potential must have a negative pregnancy test on treatment day
- Preference for non-surgical management after consultation with hepato-pancreato-biliary surgery
- Prior attempts at ablation by EUS-guided chemotherapy injection if not a surgical candidate
You will not qualify if you...
- Diagnosis of benign or non-neoplastic cyst such as pseudocyst confirmed by EUS-FNA and related tests
- Diagnosis of malignant pancreatic cystic neoplasm with adenocarcinoma, invasive carcinoma, or distant metastases
- Cysts or neuroendocrine tumors near blood vessels, bile ducts, or main pancreatic duct where ablation could harm these structures
- Acute pancreatitis within 4 weeks before treatment
- Severe or uncontrolled systemic diseases or lab abnormalities making participation unsafe
- Psychiatric disorders preventing reliable informed consent
- Pregnancy or breastfeeding
- Eastern Cooperative Oncology Group performance status of 4
- Contraindication to general anesthesia after preoperative assessment
- Presence of cardiac implantable electrical devices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial treatment with possible repeat procedures during surveillance
Participants undergo endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) followed by endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) of pancreatic cystic neoplasms. Some participants may have repeat EUS-RFA or EUS-guided chemoablation during this period.
1 baseline visit for treatment and additional visits as needed for repeat ablation or chemoablation
Duration - Up to 3 years
After treatment, participants are followed up every 3 to 6 months for cysts 3 cm or larger, or every 6 to 12 months for cysts smaller than 3 cm, with imaging and assessments to monitor cyst response and safety for up to 3 years.
Follow-up visits every 3-6 months or every 6-12 months depending on cyst size
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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