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

Launched by OHIO STATE UNIVERSITY COMPREHENSIVE CANCER CENTER · Jul 18, 2023

Keywords

ClinConnect Summary

The ERASE Study is a clinical trial exploring a new treatment option for patients with pancreatic tumors, particularly cysts that could potentially develop into cancer. This study is focused on a procedure called endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA), which uses heat generated by electrical energy to destroy tumor cells in a less invasive way than traditional surgery. This could be especially beneficial for patients who are not suitable candidates for surgery due to age, health conditions, or personal choice. The goal is to assess how safe and effective this treatment is, potentially reducing the need for frequent monitoring of pancreatic tumors.

To be eligible for the trial, participants must be at least 18 years old and have a specific type of pancreatic cyst that measures at least 2 cm and shows concerning features. They should not be candidates for surgery due to various reasons, such as advanced age or significant health issues. Participants will receive the EUS-RFA treatment during a routine endoscopic ultrasound examination, and the study will monitor their safety and the outcome of the treatment. This trial is crucial as it aims to provide a new management option for high-risk pancreatic tumors, which can be challenging to treat and often have poor outcomes.

Gender

ALL

Eligibility 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