Endoscopic Ultrasound-guided Radiofrequency Ablation of Pancreatic Cysts (ERASE)

Launched by OHIO STATE UNIVERSITY · Jun 14, 2023

Keywords

ClinConnect Summary

The ERASE trial is investigating a new treatment method called endoscopic ultrasound-guided radiofrequency ablation (EUS-guided RFA) for patients with pancreatic cysts that could potentially become harmful. This study aims to determine how safe and effective this treatment is for patients who cannot undergo traditional surgery due to various health reasons. Eligible participants are adults over 18 years old who have been diagnosed with certain types of pancreatic cysts that are concerning and measure at least 2 cm. They must not be candidates for surgery after consultation with medical specialists.

If you decide to participate, you will undergo the EUS-guided RFA treatment and then have regular check-ups for three years to monitor your health and the status of the cysts. The trial is currently recruiting participants, and it's important to know that you must be able to provide informed consent and meet specific health criteria. This study offers an opportunity for individuals who prefer a non-surgical approach to manage their condition safely.

Gender

All

Eligibility criteria

• Inclusion Criteria:
• • Age >18 years.
• • A diagnosis of a PCN confirmed by EUS-FNA including cyst fluid NGS and/or EUS-nCLE and/or EUS-TTNB (through the needle biopsy).
• • The 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 after consultation with Hepato-Pancreato-Biliary (HPB) surgery and/or review in the pancreatic multi-disciplinary tumor board conference.
• • Common clinical scenarios include -
• • Cirrhosis of the liver (common clinical scenario)
• • Advanced 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.
• • 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 (OSU 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 NETS (neuroendocrine tumors) involving or in close proximity to blood vessels or the biliary tree where the zone of ablation is likely to compromise these structures.
• • PCNs such as IPMNs involving the main pancreatic duct as in mixed-IPMN lesions.
• • 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.
• • ECOG performance status 4.
• • Contraindication to general anesthesia after review by OSU Preoperative Assessment Clinic (OPAC)
• • Cardiac Implantable Electrical Devices