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Evaluation of Endoscopic Ultrasound-Guided Radiofrequency Ablation for the Management of Pancreatic Tumors, ERASE Study (ERASE)

Primary Purpose

Pancreatic Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chemical Ablation
Computed Tomography
Electronic Health Record Review
Endoscopic Ultrasound-Guided Fine-Needle Aspiration
Endoscopic Ultrasound-Guided Radiofrequency Ablation
Magnetic Resonance Cholangiopancreatography
Magnetic Resonance Imaging
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreatic Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age > 18 years A diagnosis of a PCN confirmed by EUS-FNA including cyst fluid next generation sequencing (NGS) and/or EUS-guided needle-based confocal laser endomicroscopy (nCLE) and/or EUS- guided through-the-needle biopsy (TTNB) The pancreatic cystic lesion (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. Common clinical scenarios include - Cirrhosis of the liver (common clinical scenario) Advanced ( >= 75 years) 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 (Ohio State University [OSU] Institutional Review Board [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 neuroendocrine tumors (NETS) involving or in close proximity to blood vessels, the biliary tree, or the main pancreatic duct where the zone of ablation is likely to compromise these structures 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 Eastern Cooperative Oncology Group (ECOG) performance status 4 Contraindication to general anesthesia after review by OSU Preoperative Assessment Clinic (OPAC) Cardiac implantable electrical devices

Sites / Locations

  • Ohio State University Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (EUS-RFA)

Arm Description

Patients undergo standard of care EUS-FNA followed by EUS-RFA on study and may undergo repeat EUS-RFA or EUS-guided chemoablation during surveillance. Patients undergo MRI/MRCP, CT, or EUS-FNA at baseline and at follow-up timepoints.

Outcomes

Primary Outcome Measures

Efficacy of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA)
Defined as at least a 50% decrease in the cyst diameter. Other markers of response to EUS-RFA will be evaluated by cross-sectional imaging and EUS: change in the diameter, morphology of cyst - fibrosis, septations, loculations, wall thickness, intracystic or mural nodules; cyst fluid aspiration (biopsy if there is fibrosis): next generation sequencing (NGS) - persistence or absence of mutations (molecular markers), cytology - results can include either: mucin, atypical/suspicious cells, necrotic material, or inflammatory debris, experimental: flow cytometry for immunological markers of antineoplastic response; serological changes: chromogranin A (for cystic-neuroendocrine tumor), and serum cancer antigen (CA) 19-9 (if elevated prior to intervention).

Secondary Outcome Measures

Long-term response to EUS-RFA
Defined as at least a 50% decrease in the cyst diameter. Durable response: Continued response with further decrease in cyst diameter beyond the first calendar year. The response will be evaluated by cross-sectional imaging and EUS: change in the diameter, morphology of cyst - fibrosis, septations, loculations, wall thickness, intracystic or mural nodules; cyst fluid aspiration (biopsy if there is fibrosis): NGS - persistence or absence of mutations (molecular markers), cytology - results can include either: mucin, atypical/suspicious cells, necrotic material, or inflammatory debris, experimental: flow cytometry for immunological markers of antineoplastic response; serological changes: chromogranin A (for cystic-neuroendocrine tumor), and serum CA 19-9 (if elevated prior to intervention).
Safety of EUS-guided RFA of pancreatic cystic neoplasms post procedure
Documented using the adverse events in gastrointestinal endoscopy classification for adverse events in gastrointestinal advanced endoscopy. Only grade II or higher degree of complications will be documented since patients are electively admitted after EUS-RFA for overnight observation. If patient has post-procedure acute pancreatitis, document severity based on Revised Atlanta Classification.
Safety of EUS-guided RFA of pancreatic cystic neoplasms at one year
Documented using the adverse events in gastrointestinal endoscopy classification for adverse events in gastrointestinal advanced endoscopy. Only grade II or higher degree of complications will be documented since patients are electively admitted after EUS-RFA for overnight observation. If patient has post-procedure acute pancreatitis, document severity based on Revised Atlanta Classification.

Full Information

First Posted
July 11, 2023
Last Updated
July 18, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05961982
Brief Title
Evaluation of Endoscopic Ultrasound-Guided Radiofrequency Ablation for the Management of Pancreatic Tumors, ERASE Study
Acronym
ERASE
Official Title
Endoscopic Ultrasound-Guided Radiofrequency Ablation of Pancreatic Cysts - A Safety and Efficacy Trial (ERASE Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical trial evaluates the safety and effectiveness of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) for the management of patients with pancreatic tumors (including cysts) performed during recommended surveillance endoscopic ultrasound examinations. Pancreatic tumors (cysts) can progress to pancreatic cancer at rate of more than 25% per year risk. Pancreatic cancer is a fatal disease that is difficult to diagnose at an early stage, and the five-year survival rate is currently less than 10%. It is projected to be the second leading cause of cancer-related mortality by the year 2030. A procedure known as radiofrequency ablation may help. Radiofrequency ablation is an established way to treat benign and cancerous tumors in the human body. In the last 5 years, radiofrequency ablation has been applied to treat precancerous tumors (including cysts) in the pancreas. This procedure implements a medical technology that destroys tumors in a much less invasive way compared to traditional surgical removal. By delivering a high-frequency alternating current, radiofrequency ablation uses electrical energy and heat to destroy cancer cells. Radiofrequency ablation is being recognized as a management option in patients with high-risk pancreatic tumors (cysts) but are not deemed surgical candidates. While surgical removal offers a chance of cure, pancreatic surgeries have 20-40% morbidity rate (short and long-term complication) and a 1-2% mortality rate in patients who are surgical candidates. Furthermore, radiofrequency ablation can potentially decrease the need for frequent imaging/surveillance of the pancreatic tumor (cyst). In patients with immediate prohibitive, but reversible risks for surgery, radiofrequency ablation of a high-risk tumors (cysts) can potentially prevent further progression of the lesion and bridge the time before the need for surgical resection.
Detailed Description
PRIMARY OBJECTIVE: I. To assess the efficacy of EUS-RFA of pancreatic cystic neoplasms (PCNs). SECONDARY OBJECTIVES: I. To assess the safety of EUS-guided RFA of PCNs. II. To assess the long-term response to EUS-RFA. OUTLINE: Patients undergo standard of care EUS-fine-needle aspiration (FNA) followed by EUS-RFA on study and may undergo repeat EUS-RFA or EUS-guided chemoablation during surveillance. Patients undergo magnetic resonance imaging (MRI)/magnetic resonance cholangiopancreatography (MRCP), computed tomography (CT), or EUS-FNA at baseline and at follow-up timepoints. After completion of study treatment, patients are followed up every 3-6 months for cysts >= 3 cm or every 6-12 months for cysts < 3 cm for up to 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasm

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (EUS-RFA)
Arm Type
Experimental
Arm Description
Patients undergo standard of care EUS-FNA followed by EUS-RFA on study and may undergo repeat EUS-RFA or EUS-guided chemoablation during surveillance. Patients undergo MRI/MRCP, CT, or EUS-FNA at baseline and at follow-up timepoints.
Intervention Type
Procedure
Intervention Name(s)
Chemical Ablation
Other Intervention Name(s)
ABLATION, CHEMICAL
Intervention Description
Undergo EUS-guided chemoablation
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo CT
Intervention Type
Other
Intervention Name(s)
Electronic Health Record Review
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Ultrasound-Guided Fine-Needle Aspiration
Other Intervention Name(s)
endoscopic ultrasound-guided fine needle aspiration, EUS-FNA
Intervention Description
Undergo EUS-FNA
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Ultrasound-Guided Radiofrequency Ablation
Other Intervention Name(s)
EUS-RFA
Intervention Description
Undergo EUS-RFA
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Cholangiopancreatography
Other Intervention Name(s)
MRCP
Intervention Description
Undergo MRI/MRCP
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo MRI/MRCP
Primary Outcome Measure Information:
Title
Efficacy of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA)
Description
Defined as at least a 50% decrease in the cyst diameter. Other markers of response to EUS-RFA will be evaluated by cross-sectional imaging and EUS: change in the diameter, morphology of cyst - fibrosis, septations, loculations, wall thickness, intracystic or mural nodules; cyst fluid aspiration (biopsy if there is fibrosis): next generation sequencing (NGS) - persistence or absence of mutations (molecular markers), cytology - results can include either: mucin, atypical/suspicious cells, necrotic material, or inflammatory debris, experimental: flow cytometry for immunological markers of antineoplastic response; serological changes: chromogranin A (for cystic-neuroendocrine tumor), and serum cancer antigen (CA) 19-9 (if elevated prior to intervention).
Time Frame
At 1 years after EUS-RFA
Secondary Outcome Measure Information:
Title
Long-term response to EUS-RFA
Description
Defined as at least a 50% decrease in the cyst diameter. Durable response: Continued response with further decrease in cyst diameter beyond the first calendar year. The response will be evaluated by cross-sectional imaging and EUS: change in the diameter, morphology of cyst - fibrosis, septations, loculations, wall thickness, intracystic or mural nodules; cyst fluid aspiration (biopsy if there is fibrosis): NGS - persistence or absence of mutations (molecular markers), cytology - results can include either: mucin, atypical/suspicious cells, necrotic material, or inflammatory debris, experimental: flow cytometry for immunological markers of antineoplastic response; serological changes: chromogranin A (for cystic-neuroendocrine tumor), and serum CA 19-9 (if elevated prior to intervention).
Time Frame
At 2 and 3 years after EUS-RFA
Title
Safety of EUS-guided RFA of pancreatic cystic neoplasms post procedure
Description
Documented using the adverse events in gastrointestinal endoscopy classification for adverse events in gastrointestinal advanced endoscopy. Only grade II or higher degree of complications will be documented since patients are electively admitted after EUS-RFA for overnight observation. If patient has post-procedure acute pancreatitis, document severity based on Revised Atlanta Classification.
Time Frame
Post-procedure (after EUS-RFA)
Title
Safety of EUS-guided RFA of pancreatic cystic neoplasms at one year
Description
Documented using the adverse events in gastrointestinal endoscopy classification for adverse events in gastrointestinal advanced endoscopy. Only grade II or higher degree of complications will be documented since patients are electively admitted after EUS-RFA for overnight observation. If patient has post-procedure acute pancreatitis, document severity based on Revised Atlanta Classification.
Time Frame
at one year after EUS-RFA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years A diagnosis of a PCN confirmed by EUS-FNA including cyst fluid next generation sequencing (NGS) and/or EUS-guided needle-based confocal laser endomicroscopy (nCLE) and/or EUS- guided through-the-needle biopsy (TTNB) The pancreatic cystic lesion (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. Common clinical scenarios include - Cirrhosis of the liver (common clinical scenario) Advanced ( >= 75 years) 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 (Ohio State University [OSU] Institutional Review Board [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 neuroendocrine tumors (NETS) involving or in close proximity to blood vessels, the biliary tree, or the main pancreatic duct where the zone of ablation is likely to compromise these structures 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 Eastern Cooperative Oncology Group (ECOG) performance status 4 Contraindication to general anesthesia after review by OSU Preoperative Assessment Clinic (OPAC) Cardiac implantable electrical devices
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
The Ohio State University Comprehensive Cancer Center
Phone
800-293-5066
Email
OSUCCCClinicaltrials@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Somashekar G Krishna, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Somashekar G. Krishna, MD
Phone
614-293-6255
Email
Somashekar.Krishna@osumc.edu
First Name & Middle Initial & Last Name & Degree
Somashekar G. Krishna, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

Evaluation of Endoscopic Ultrasound-Guided Radiofrequency Ablation for the Management of Pancreatic Tumors, ERASE Study

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