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

Last updated: June 14, 2023
Sponsor: Ohio State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatitis

Treatment

EUS-guided radiofrequency ablation of pancreatic cyst

FDA-cleared device (EUS-RFA probe)

Clinical Study ID

NCT05916846
2023C0004
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age >18 years.
  2. A diagnosis of a PCN confirmed by EUS-FNA including cyst fluid NGS and/or EUS-nCLEand/or EUS-TTNB (through the needle biopsy).
  3. The PCL measures at least 2 cm in diameter on either CT or MRI/MRCP or EUS anddemonstrates concerning worrisome and/or high-risk features as defined byInternational Consensus Guidelines (2017 revised Fukuoka Guidelines).
  4. The patient is not a surgical candidate after consultation withHepato-Pancreato-Biliary (HPB) surgery and/or review in the pancreaticmulti-disciplinary tumor board conference. Common clinical scenarios include -
  5. Cirrhosis of the liver (common clinical scenario)
  6. Advanced age (common clinical scenario)
  7. Morbid obesity
  8. Significant cardiorespiratory comorbidity
  9. Patient's choice (patient elects for non-surgical management)
  10. Other significant comorbid conditions that impose prohibitive surgical risks
  11. Estimated life expectancy of at least 1 year.
  12. Capable of giving written informed consent.
  13. Women of childbearing potential must have a negative pregnancy test (serum/urine) onthe day of treatment. Pregnancy testing is the routine standard of care practice inthe endoscopy laboratory for all patients undergoing endoscopy and sedation forendoscopy.
  14. The patient prefers non-surgical management after consultation withHepato-Pancreato-Biliary (HPB) surgery
  15. The patient is not a surgical candidate and has had prior attempts at ablation of thePCN by EUS-guided injection of chemotherapy (OSU IRB protocol 2020C0198)

Exclusion

Exclusion Criteria:

  1. A diagnosis of a benign or non-neoplastic PCL such as a pseudocyst confirmed byEUS-FNA including cyst fluid NGS and/or EUS-nCLE and/or EUS-TTNB.
  2. A diagnosis of a malignant PCN confirmed by evidence of adenocarcinoma and/or invasivecarcinoma and/or distant metastases
  3. Cysts or NETS (neuroendocrine tumors) involving or in close proximity to blood vesselsor the biliary tree where the zone of ablation is likely to compromise thesestructures.
  4. PCNs such as IPMNs involving the main pancreatic duct as in mixed-IPMN lesions.
  5. Acute pancreatitis in the preceding 4 weeks prior to date of EUS-RFA
  6. Any evidence of severe or uncontrolled systemic diseases or laboratory finding that inthe view of the investigator makes it unsafe for the patient to participate in thestudy.
  7. Any psychiatric disorder making reliable informed consent impossible.
  8. Pregnancy or breast-feeding.
  9. ECOG performance status 4.
  10. Contraindication to general anesthesia after review by OSU Preoperative AssessmentClinic (OPAC)
  11. Cardiac Implantable Electrical Devices

Study Design

Total Participants: 28
Treatment Group(s): 2
Primary Treatment: EUS-guided radiofrequency ablation of pancreatic cyst
Phase:
Study Start date:
April 24, 2023
Estimated Completion Date:
April 30, 2026

Study 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
  1. (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).

  1. 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).

  2. 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
    2. 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

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

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

  5. 3 calendar years of documentation for study purposes

Connect with a study center

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

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