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

Pancreatic Cyst Clinical Trial

Official title: EUS-Guided Radiofrequency Ablation of Pancreatic Cysts - A Safety and Efficacy Trial

Status Recruiting

Clinical Trial Summary

A single-center study to determine the safety and efficacy of EUS-guided radiofrequency ablation (RFA) of pancreatic cystic neoplasms (PCNs). Patients will be recruited sequentially to undergo RFA followed by standard surveillance. The study will recruit patients with pancreatic cystic lesions (PCLs) who are at high risk for surgical resection. Patients enrolled in the study will be followed up for 3-years after EUS-guided RFA.

Clinical Trial Description

This is a single-center prospective study evaluating EUS-guided RFA of PCNs (Figure 1). The study plans to enroll patients over a 3-year duration. Patients with a definitive diagnosis of a PCN and with prohibitive risks for surgery will be recruited sequentially to undergo EUS-guided RFA followed by standard of care surveillance.

The following assessments will be completed. Pre-recruitment radiological and EUS investigations should be performed within 3-6 months of planned enrollment and treatment. The pre-recruitment evaluation is part of the routine standard of care (SOC) assessment of PCNs.

• Pre-treatment/ Baseline These are standard of care practices for management of PCNs defined by International Consensus Guidelines (ICG) and American College of Gastroenterology PCL Guidelines.

Pre-treatment requirements:

1. MRI/MRCP (month -6 to day 0). Imaging will not be performed if already available as part of standard of practice in managing PCLs 2. Pancreatic protocol CT abdomen (month -6 to day 0) (if a patient cannot undergo MRI/MRCP) 3. Physical examination (including ECOG (Eastern Cooperative Oncology Group) performance status) 4. Laboratory: Complete Blood Count (CBC), Basic Metabolic Panel (BMP), Liver Function Tests (LFTs), Prothrombin Time (PT) Test & International Normalised Ratio (INR) blood test, serum CA19-9 (cancer antigen 19-9), serum amylase, lipase, Chromogranin A (for cystic-NET). Laboratory tests will not be performed if already available as part of the standard of practice in managing PCLs and standard of care prior to routine EUS-FNA (fine needle aspiration).

5. EUS with FNA (as per ICG) with at least one of the following advanced diagnostics - EUS-nCLE (needle-guided confocal laser endomicroscopy) or cyst fluid analysis by NGS (Next-generation sequencing).

6. Experimental arm: Cyst fluid will also be sent for pre-treatment flow cytometry for immunological markers of antineoplastic response (baseline)

• Treatment (Day 0):

1. Physical examination

2. Informed consent

3. Pregnancy tests when indicated, will not be performed if already available as part of the standard of practice in managing PCLs and standard of care prior to routine EUS-FNA.

4. Administration of pre-procedure prophylaxis against post-EUS-RFA pancreatitis. This is the standard prophylaxis used to prevent pancreatitis during ERCP (Endoscopic retrograde cholangiopancreatography) procedures. This will involve Ringers Lactate as choice of IV fluid, per rectal indomethacin administered during the procedure, and only clear liquid diet is permitted post-procedure (till next morning).

5. One dose IV quinolone antibiotic (or equivalent if patient has allergy to quinolones)

6. Anesthesia: The standard of practice anesthesia required for any EUS procedure will be applied during the procedure. Anesthesia can be either Monitored Anesthesia Care (MAC) or general. As per standard practice, all patients referred for EUS will undergo nursing triage. If and when indicated, patients will be referred to OSU Preoperative Assessment Clinic (OPAC) for review by anesthesia prior to the procedure.

7. EUS-FNA (if sufficient send for cyst fluid analysis as per SOC) and EUS-RFA of PCN

8. Inpatient admission for overnight observation

9. Apply AGREE classification for adverse events, document only Grade II and above since patients are admitted for observation

10. If patient has post-procedure acute pancreatitis, document severity based on Revised Atlanta Classification

• Post-procedure day # 1:

1. Symptom and adverse event monitoring - AGREE classification and Revised Atlanta Classification (Appendix 3) in patients with acute pancreatitis 2. Physical examination

3. Laboratory: CBC, BMP, LFTs, Lipase on post-procedure day # 1

• Follow-up & response assessment These are standard of care practices for the management of PCNs defined by International Consensus Guidelines (ICG)3 and/or American College of Gastroenterology Guidelines.21

For cyst ≥ 3 cm, follow-up is every 3-6 months 1. Physical examination (including ECOG (performance status) 2. Imaging with MRI/MRCP or CT abdomen (pancreatic protocol) For cysts < 3 cm, follow-up is every 6-12 months

1. Physical examination (including ECOG performance status)

2. Imaging with MRI/MRCP or CT abdomen (pancreatic protocol) For all cysts

1. Alternate MRI/MRCP (or CT imaging) with EUS every 6 months to 1 year (SOC, ICG cyst guidelines) Total duration of follow-up

1. Indefinitely as per standard of care in patients with pancreatic cysts (SOC, ICG cyst guidelines)

2. 3 calendar years of documentation for study purposes ;

Related Conditions & MeSH terms

• Cysts
• Pancreatic Cyst
• Radiofrequency Ablation

• NCT number: NCT05916846
• Study type: Interventional
• Source: Ohio State University
• Contact: Somashekar G Krishna, MD, MPH
• Phone: 614-366-8716
• Email: somashekar.krishna@osumc.edu
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2023
• Completion date: April 30, 2026