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

June 14, 2023 updated by: Somashekar Krishna, Ohio State University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age >18 years.
  2. 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).
  3. 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).

  4. 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 -

    1. Cirrhosis of the liver (common clinical scenario)
    2. Advanced age (common clinical scenario)
    3. Morbid obesity
    4. Significant cardiorespiratory comorbidity
    5. Patient's choice (patient elects for non-surgical management)
    6. Other significant comorbid conditions that impose prohibitive surgical risks
  5. Estimated life expectancy of at least 1 year.
  6. Capable of giving written informed consent.
  7. 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.
  8. The patient prefers non-surgical management after consultation with Hepato-Pancreato-Biliary (HPB) surgery
  9. 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:

  1. 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.
  2. A diagnosis of a malignant PCN confirmed by evidence of adenocarcinoma and/or invasive carcinoma and/or distant metastases
  3. 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.
  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 in the view of the investigator makes it unsafe for the patient to participate in the study.
  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 Assessment Clinic (OPAC)
  11. Cardiac Implantable Electrical Devices

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: EUS-guided radiofrequency ablation of pancreatic cystic lesion(s)
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).
Procedure: EUS-guided radiofrequency ablation of pancreatic cyst
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.
Device: FDA-cleared device (EUS-RFA probe)
FDA-cleared device (EUS-RFA probe).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the efficacy of EUS-RFA post-procedure after one year
Time Frame: At one calendar year after EUS-RFA procedure

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)
At one calendar year after EUS-RFA procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Time point 1: Immediately post-procedure (after EUS-RFA) in endoscopy unit up to 24 hours after procedure; Time point 2: At one calendar year after EUS-RFA

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.
Time point 1: Immediately post-procedure (after EUS-RFA) in endoscopy unit up to 24 hours after procedure; Time point 2: At one calendar year after EUS-RFA
Assess the long-term response to EUS-RFA for efficacy of significant and durable ablation response
Time Frame: At two and three calendar years after EUS-RFA

  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)
At two and three calendar years after EUS-RFA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

April 26, 2023

First Submitted That Met QC Criteria

June 14, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Actual)

June 23, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023C0004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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