xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05961982</url>
    </required_header>
    <id_info>
      <org_study_id>OSU-22277</org_study_id>
      <secondary_id>NCI-2023-04688</secondary_id>
      <nct_id>NCT05961982</nct_id>
    </id_info>
    <brief_title>Evaluation of Endoscopic Ultrasound-Guided Radiofrequency Ablation for the Management of Pancreatic Tumors, ERASE Study</brief_title>
    <acronym>ERASE</acronym>
    <official_title>Endoscopic Ultrasound-Guided Radiofrequency Ablation of Pancreatic Cysts - A Safety and Efficacy Trial (ERASE Study)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ohio State University Comprehensive Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ohio State University Comprehensive Cancer Center</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This clinical trial evaluates the safety and effectiveness of endoscopic ultrasound-guided&#xD;
        radiofrequency ablation (EUS-RFA) for the management of patients with pancreatic tumors&#xD;
        (including cysts) performed during recommended surveillance endoscopic ultrasound&#xD;
        examinations. Pancreatic tumors (cysts) can progress to pancreatic cancer at rate of more&#xD;
        than 25% per year risk. Pancreatic cancer is a fatal disease that is difficult to diagnose at&#xD;
        an early stage, and the five-year survival rate is currently less than 10%. It is projected&#xD;
        to be the second leading cause of cancer-related mortality by the year 2030. A procedure&#xD;
        known as radiofrequency ablation may help. Radiofrequency ablation is an established way to&#xD;
        treat benign and cancerous tumors in the human body. In the last 5 years, radiofrequency&#xD;
        ablation has been applied to treat precancerous tumors (including cysts) in the pancreas.&#xD;
        This procedure implements a medical technology that destroys tumors in a much less invasive&#xD;
        way compared to traditional surgical removal. By delivering a high-frequency alternating&#xD;
        current, radiofrequency ablation uses electrical energy and heat to destroy cancer cells.&#xD;
        Radiofrequency ablation is being recognized as a management option in patients with high-risk&#xD;
        pancreatic tumors (cysts) but are not deemed surgical candidates. While surgical removal&#xD;
        offers a chance of cure, pancreatic surgeries have 20-40% morbidity rate (short and long-term&#xD;
        complication) and a 1-2% mortality rate in patients who are surgical candidates. Furthermore,&#xD;
        radiofrequency ablation can potentially decrease the need for frequent imaging/surveillance&#xD;
        of the pancreatic tumor (cyst). In patients with immediate prohibitive, but reversible risks&#xD;
        for surgery, radiofrequency ablation of a high-risk tumors (cysts) can potentially prevent&#xD;
        further progression of the lesion and bridge the time before the need for surgical resection.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVE:&#xD;
  &#xD;
        I. To assess the efficacy of EUS-RFA of pancreatic cystic neoplasms (PCNs).&#xD;
  &#xD;
        SECONDARY OBJECTIVES:&#xD;
  &#xD;
        I. To assess the safety of EUS-guided RFA of PCNs. II. To assess the long-term response to&#xD;
        EUS-RFA.&#xD;
  &#xD;
        OUTLINE:&#xD;
  &#xD;
        Patients undergo standard of care EUS-fine-needle aspiration (FNA) followed by EUS-RFA on&#xD;
        study and may undergo repeat EUS-RFA or EUS-guided chemoablation during surveillance.&#xD;
        Patients undergo magnetic resonance imaging (MRI)/magnetic resonance cholangiopancreatography&#xD;
        (MRCP), computed tomography (CT), or EUS-FNA at baseline and at follow-up timepoints.&#xD;
  &#xD;
        After completion of study treatment, patients are followed up every 3-6 months for cysts &gt;= 3&#xD;
        cm or every 6-12 months for cysts &lt; 3 cm for up to 3 years.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 24, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Efficacy of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA)</measure>
      <time_frame>At 1 years after EUS-RFA</time_frame>
      <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).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Long-term response to EUS-RFA</measure>
      <time_frame>At 2 and 3 years after EUS-RFA</time_frame>
      <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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety of EUS-guided RFA of pancreatic cystic neoplasms post procedure</measure>
      <time_frame>Post-procedure (after EUS-RFA)</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety of EUS-guided RFA of pancreatic cystic neoplasms at one year</measure>
      <time_frame>at one year after EUS-RFA</time_frame>
      <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.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Pancreatic Neoplasm</condition>
    <arm_group>
      <arm_group_label>Treatment (EUS-RFA)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Chemical Ablation</intervention_name>
      <description>Undergo EUS-guided chemoablation</description>
      <arm_group_label>Treatment (EUS-RFA)</arm_group_label>
      <other_name>ABLATION, CHEMICAL</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Computed Tomography</intervention_name>
      <description>Undergo CT</description>
      <arm_group_label>Treatment (EUS-RFA)</arm_group_label>
      <other_name>CAT</other_name>
      <other_name>CAT Scan</other_name>
      <other_name>Computed Axial Tomography</other_name>
      <other_name>Computerized Axial Tomography</other_name>
      <other_name>Computerized axial tomography (procedure)</other_name>
      <other_name>Computerized Tomography</other_name>
      <other_name>CT</other_name>
      <other_name>CT Scan</other_name>
      <other_name>tomography</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Electronic Health Record Review</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Treatment (EUS-RFA)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Endoscopic Ultrasound-Guided Fine-Needle Aspiration</intervention_name>
      <description>Undergo EUS-FNA</description>
      <arm_group_label>Treatment (EUS-RFA)</arm_group_label>
      <other_name>endoscopic ultrasound-guided fine needle aspiration</other_name>
      <other_name>EUS-FNA</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Endoscopic Ultrasound-Guided Radiofrequency Ablation</intervention_name>
      <description>Undergo EUS-RFA</description>
      <arm_group_label>Treatment (EUS-RFA)</arm_group_label>
      <other_name>EUS-RFA</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Magnetic Resonance Cholangiopancreatography</intervention_name>
      <description>Undergo MRI/MRCP</description>
      <arm_group_label>Treatment (EUS-RFA)</arm_group_label>
      <other_name>MRCP</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Magnetic Resonance Imaging</intervention_name>
      <description>Undergo MRI/MRCP</description>
      <arm_group_label>Treatment (EUS-RFA)</arm_group_label>
      <other_name>Magnetic Resonance</other_name>
      <other_name>Magnetic resonance imaging (procedure)</other_name>
      <other_name>Magnetic Resonance Imaging Scan</other_name>
      <other_name>Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance</other_name>
      <other_name>MR</other_name>
      <other_name>MR Imaging</other_name>
      <other_name>MRI</other_name>
      <other_name>MRI Scan</other_name>
      <other_name>NMR Imaging</other_name>
      <other_name>NMRI</other_name>
      <other_name>Nuclear Magnetic Resonance Imaging</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt; 18 years&#xD;
  &#xD;
            -  A diagnosis of a PCN confirmed by EUS-FNA including cyst fluid next generation&#xD;
               sequencing (NGS) and/or EUS-guided needle-based confocal laser endomicroscopy (nCLE)&#xD;
               and/or EUS- guided through-the-needle biopsy (TTNB)&#xD;
  &#xD;
            -  The pancreatic cystic lesion (PCL) measures at least 2 cm in diameter on either CT or&#xD;
               MRI/MRCP or EUS and demonstrates concerning worrisome and/or high-risk features as&#xD;
               defined by International Consensus Guidelines (2017 revised Fukuoka Guidelines)&#xD;
  &#xD;
            -  The patient is not a surgical candidate. Common clinical scenarios include -&#xD;
  &#xD;
                 -  Cirrhosis of the liver (common clinical scenario)&#xD;
  &#xD;
                 -  Advanced ( &gt;= 75 years) age (common clinical scenario)&#xD;
  &#xD;
                 -  Morbid obesity&#xD;
  &#xD;
                 -  Significant cardiorespiratory comorbidity&#xD;
  &#xD;
                 -  Patient's choice (patient elects for non-surgical management)&#xD;
  &#xD;
                 -  Other significant comorbid conditions that impose prohibitive surgical risks&#xD;
  &#xD;
            -  Estimated life expectancy of at least 1 year&#xD;
  &#xD;
            -  Capable of giving written informed consent&#xD;
  &#xD;
            -  Women of childbearing potential must have a negative pregnancy test (serum/urine) on&#xD;
               the day of treatment. Pregnancy testing is the routine standard of care practice in&#xD;
               the endoscopy laboratory for all patients undergoing endoscopy and sedation for&#xD;
               endoscopy&#xD;
  &#xD;
            -  The patient prefers non-surgical management after consultation with&#xD;
               hepato-pancreato-biliary (HPB) surgery&#xD;
  &#xD;
            -  The patient is not a surgical candidate and has had prior attempts at ablation of the&#xD;
               PCN by EUS-guided injection of chemotherapy (Ohio State University [OSU] Institutional&#xD;
               Review Board [IRB] protocol 2020C0198)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  A diagnosis of a benign or non-neoplastic PCL such as a pseudocyst confirmed by&#xD;
               EUS-FNA including cyst fluid NGS and/or EUS-nCLE and/or EUS-TTNB&#xD;
  &#xD;
            -  A diagnosis of a malignant PCN confirmed by evidence of adenocarcinoma and/or invasive&#xD;
               carcinoma and/or distant metastases&#xD;
  &#xD;
            -  Cysts or neuroendocrine tumors (NETS) involving or in close proximity to blood&#xD;
               vessels, the biliary tree, or the main pancreatic duct where the zone of ablation is&#xD;
               likely to compromise these structures&#xD;
  &#xD;
            -  Acute pancreatitis in the preceding 4 weeks prior to date of EUS-RFA&#xD;
  &#xD;
            -  Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in&#xD;
               the view of the investigator makes it unsafe for the patient to participate in the&#xD;
               study&#xD;
  &#xD;
            -  Any psychiatric disorder making reliable informed consent impossible&#xD;
  &#xD;
            -  Pregnancy or breast-feeding&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status 4&#xD;
  &#xD;
            -  Contraindication to general anesthesia after review by OSU Preoperative Assessment&#xD;
               Clinic (OPAC)&#xD;
  &#xD;
            -  Cardiac implantable electrical devices&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Somashekar G Krishna, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ohio State University Comprehensive Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>The Ohio State University Comprehensive Cancer Center</last_name>
      <phone>800-293-5066</phone>
      <email>OSUCCCClinicaltrials@osumc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ohio State University Comprehensive Cancer Center</name>
        <address>
          <city>Columbus</city>
          <state>Ohio</state>
          <zip>43210</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Somashekar G. Krishna, MD</last_name>
        <phone>614-293-6255</phone>
        <email>Somashekar.Krishna@osumc.edu</email>
      </contact>
      <investigator>
        <last_name>Somashekar G. Krishna, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://cancer.osu.edu</url>
      <description>The Jamesline</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ohio State University Comprehensive Cancer Center</investigator_affiliation>
      <investigator_full_name>Somashekar Krishna</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pancreatic Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05961982
  org study id: OSU-22277
  secondary id: NCI-2023-04688
  nct id: NCT05961982
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Efficacy of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA)
  time frame: At 1 years after 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).
  measure: Long-term response to EUS-RFA
  time frame: At 2 and 3 years after 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).
  measure: Safety of EUS-guided RFA of pancreatic cystic neoplasms post procedure
  time frame: Post-procedure (after EUS-RFA)
  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.
  measure: Safety of EUS-guided RFA of pancreatic cystic neoplasms at one year
  time frame: at one year after EUS-RFA
  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.
  arm group label: Treatment (EUS-RFA)
  arm group type: Experimental
  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: Chemical Ablation
  description: Undergo EUS-guided chemoablation
  arm group label: Treatment (EUS-RFA)
  other name: ABLATION, CHEMICAL
  intervention type: Procedure
  intervention name: Computed Tomography
  description: Undergo CT
  arm group label: Treatment (EUS-RFA)
  other name: CAT
  other name: CAT Scan
  other name: Computed Axial Tomography
  other name: Computerized Axial Tomography
  other name: Computerized axial tomography (procedure)
  other name: Computerized Tomography
  other name: CT
  other name: CT Scan
  other name: tomography
  intervention type: Other
  intervention name: Electronic Health Record Review
  description: Ancillary studies
  arm group label: Treatment (EUS-RFA)
  intervention type: Procedure
  intervention name: Endoscopic Ultrasound-Guided Fine-Needle Aspiration
  description: Undergo EUS-FNA
  arm group label: Treatment (EUS-RFA)
  other name: endoscopic ultrasound-guided fine needle aspiration
  other name: EUS-FNA
  intervention type: Procedure
  intervention name: Endoscopic Ultrasound-Guided Radiofrequency Ablation
  description: Undergo EUS-RFA
  arm group label: Treatment (EUS-RFA)
  other name: EUS-RFA
  intervention type: Procedure
  intervention name: Magnetic Resonance Cholangiopancreatography
  description: Undergo MRI/MRCP
  arm group label: Treatment (EUS-RFA)
  other name: MRCP
  intervention type: Procedure
  intervention name: Magnetic Resonance Imaging
  description: Undergo MRI/MRCP
  arm group label: Treatment (EUS-RFA)
  other name: Magnetic Resonance
  other name: Magnetic resonance imaging (procedure)
  other name: Magnetic Resonance Imaging Scan
  other name: Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  other name: MR
  other name: MR Imaging
  other name: MRI
  other name: MRI Scan
  other name: NMR Imaging
  other name: NMRI
  other name: Nuclear Magnetic Resonance Imaging
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Somashekar G Krishna, MD
  role: Principal Investigator
  affiliation: Ohio State University Comprehensive Cancer Center
  last name: The Ohio State University Comprehensive Cancer Center
  phone: 800-293-5066
  email: OSUCCCClinicaltrials@osumc.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  url: http://cancer.osu.edu
  description: The Jamesline
  responsible party type: Principal Investigator
  investigator affiliation: Ohio State University Comprehensive Cancer Center
  investigator full name: Somashekar Krishna
  investigator title: Principal Investigator
  mesh term: Pancreatic Neoplasms
  sharing ipd: No