Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05961982

Evaluation of Endoscopic Ultrasound-Guided Radiofrequency Ablation for the Management of Pancreatic Tumors, ERASE Study

Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-03-23

84

Participants Needed

1

Research Sites

296 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This clinical trial evaluates the safety and effectiveness of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) for the management of patients with pancreatic tumors (including cysts) performed during recommended surveillance endoscopic ultrasound examinations. Pancreatic tumors (cysts) can progress to pancreatic cancer at rate of more than 25% per year risk. Pancreatic cancer is a fatal disease that is difficult to diagnose at an early stage, and the five-year survival rate is currently less than 10%. It is projected to be the second leading cause of cancer-related mortality by the year 2030. A procedure known as radiofrequency ablation may help. Radiofrequency ablation is an established way to treat benign and cancerous tumors in the human body. In the last 5 years, radiofrequency ablation has been applied to treat precancerous tumors (including cysts) in the pancreas. This procedure implements a medical technology that destroys tumors in a much less invasive way compared to traditional surgical removal. By delivering a high-frequency alternating current, radiofrequency ablation uses electrical energy and heat to destroy cancer cells. Radiofrequency ablation is being recognized as a management option in patients with high-risk pancreatic tumors (cysts) but are not deemed surgical candidates. While surgical removal offers a chance of cure, pancreatic surgeries have 20-40% morbidity rate (short and long-term complication) and a 1-2% mortality rate in patients who are surgical candidates. Furthermore, radiofrequency ablation can potentially decrease the need for frequent imaging/surveillance of the pancreatic tumor (cyst). In patients with immediate prohibitive, but reversible risks for surgery, radiofrequency ablation of a high-risk tumors (cysts) can potentially prevent further progression of the lesion and bridge the time before the need for surgical resection.

CONDITIONS

Official Title

Evaluation of Endoscopic Ultrasound-Guided Radiofrequency Ablation for the Management of Pancreatic Tumors, ERASE Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • Diagnosis of pancreatic cystic neoplasm confirmed by EUS-FNA with cyst fluid analysis, confocal laser endomicroscopy, or needle-based biopsy
  • Pancreatic cystic lesion measuring at least 2 cm on CT, MRI/MRCP, or EUS with high-risk features per International Consensus Guidelines
  • Patient is not a surgical candidate due to factors such as cirrhosis, advanced age (75 or older), morbid obesity, significant heart or lung disease, patient preference for non-surgical management, or other serious health conditions
  • Estimated life expectancy of at least 1 year
  • Able to provide written informed consent or have a legally authorized representative provide consent
  • Negative pregnancy test on day of treatment for women of childbearing potential
  • Patient prefers non-surgical management after consultation with surgery
  • Prior attempts at EUS-guided chemoablation of the pancreatic cystic neoplasm
Not Eligible

You will not qualify if you...

  • Diagnosis of benign or non-neoplastic pancreatic cystic lesion such as pseudocyst
  • 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 EUS-RFA
  • Severe uncontrolled systemic diseases or lab abnormalities making study participation unsafe
  • Psychiatric disorders preventing reliable informed consent
  • Pregnancy or breastfeeding
  • Eastern Cooperative Oncology Group performance status of 4
  • Contraindication to general anesthesia
  • Presence of cardiac implantable electrical devices

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

T

The Ohio State University Comprehensive Cancer Center

CONTACT

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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