Neoplasms

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Pancreatic Cyst

Pathological Conditions, Anatomical

Pancreatic Diseases

Gastrointestinal Diseases

Single arm study. EUS-guided intervention with radiofrequency ablation of pancreatic cystic lesions. Primary population of interest: Branch duct IPMN (intraductal papillary mucinous neoplasm) with high-risk for surgical intervention. The intervention is performed using an FDA-cleared device (EUS-RFA probe).

EUS-RFA is performed with an 19 Gauge RFA needle (STARMed/TaeWoong Medical USA) applying up to 30 Watt (W) current with Continuance Mode setting. RFA confirmation is confirmed endoscopically via EUS (white bubbles on EUS imaging) and impedance monitoring on the VIVA™ Combo System. Impedance has a maximum value up 800 Ohms. Sequential doses of electrical energy at 10W-30W are applied to ablate the PCN.

EUS-guided radiofrequency ablation of pancreatic cyst

FDA-cleared device (EUS-RFA probe)

Somashekar G Krishna, MD, MPH

Megan E Fry, BS

Megan Fry

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.

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

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

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

1) Significant ablation: Defined as at least a 50% decrease in the cyst diameter measured in millimeters (mm).

i) Cross-sectional imaging and EUS

(1) Change in the diameter, measured in millimeters (mm)

AND/OR

2) Resolution of pathogenic mutations ii) Cyst fluid aspiration

(1) NGS - Persistence or absence of mutations (molecular markers)

Assess the safety of EUS-guided RFA of PCNs.

1. Documented using the AGREE classification, Grade 2 or above, for adverse events in gastrointestinal advanced endoscopy.
2. Presence or absence of post-procedure acute pancreatitis, document severity based on Revised Atlanta Classification.

1. Durable response: Continued response with further decrease in cyst diameter beyond the first calendar year.

   AND/OR
2. Significant ablation: Defined as at least a 50% decrease in the cyst diameter measured in millimeters (mm).

   i) Cross-sectional imaging and EUS

(1) Change in the diameter, measured in millimeters (mm)

AND/OR

) Resolution of pathogenic mutations ii) Cyst fluid aspiration

(1) NGS - Persistence or absence of mutations (molecular markers)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endoscopic Ultrasound-guided Radiofrequency Ablation of Pancreatic Cysts (ERASE)	NCT05916846	Pancreatic Cyst Radiofrequency ...	EUS-guided radi... FDA-cleared dev...	18 Years -	Ohio State University
Endoscopic Ultrasound-guided Radiofrequency Ablation of Pancreatic Cysts (ERASE)	NCT05916846	Pancreatic Cyst Radiofrequency ...	EUS-guided radi... FDA-cleared dev...	18 Years -	Ohio State University
Endoscopic Ultrasound-guided Radiofrequency Ablation of Pancreatic Cysts (ERASE)	NCT05916846	Pancreatic Cyst Radiofrequency ...	EUS-guided radi... FDA-cleared dev...	18 Years -	Ohio State University

Spots Global Cancer Trial Database for ablation of neoplastic pancreatic cysts