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/NCT05962723</url>
    </required_header>
    <id_info>
      <org_study_id>Pancreatic cyst glucose 1</org_study_id>
      <nct_id>NCT05962723</nct_id>
    </id_info>
    <brief_title>Pancreatic Cyst Fluid Glucose: New Armamentarium in the Diagnosis of Mucinous Pancreatic Cystic Lesion</brief_title>
    <official_title>Pancreatic Cyst Fluid Glucose: New Armamentarium in the Diagnosis of Mucinous Pancreatic Cystic Lesion</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Asian Institute of Gastroenterology, India</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Asian Institute of Gastroenterology, India</source>
    <oversight_info>
      <has_dmc>No</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>
        All participants undergoing radiological imaging and found to have pancreatic cyst of size &gt;&#xD;
        2cm will be subjected to EUS (Endoscopic ultrasound) examination and cystic fluid will be&#xD;
        aspirated for analysis, including cystic fluid Glucose, CEA, amylase. Morey's biopsy will be&#xD;
        done in the cases feasible for biopsy. The sensitivity and specificity of cystic fluid&#xD;
        glucose level will be analysed taking CEA (carcinoembryonic antigen) level with EUS findings,&#xD;
        amylase level as gold standard for diagnosis, in cases with no surgical management.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pancreatic cystic lesion prevalence noted to be increased dramatically in last few decades.&#xD;
        Earlier record showed the prevalence rate of 2.4-2.6% with magnetic resonance imaging (MRI),&#xD;
        though sometimes reaching 13.5%.Recent study showed prevalence of pancreatic cysts to be 49%.&#xD;
        Most of the pancreatic cyst are benign and require conservative management and regular&#xD;
        evaluation only. Malignant cystic lesion on the other hand require immediate attention and&#xD;
        surgical excision in most of cases. Thus, diagnosis of pre-malignant &amp; malignant pancreatic&#xD;
        cyst are essential, to predict the prognosis and decide further management.&#xD;
  &#xD;
        Most widely accepted biochemical test for preoperative differentiation of mucinous from&#xD;
        benign pancreatic cysts is cystic fluid carcinoembryonic antigen (CEA). CEA with cutoff value&#xD;
        of 192 ng/ml has sensitivity, specifivcity and accuracy of 75%, 84% &amp; 79% respectively. This&#xD;
        is expensive and requires a longer duration for obtaining the results. Few recent studies&#xD;
        proposed the role of cystic fluid glucose level in the diagnosis of malignant cyst.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 20, 2023</start_date>
    <completion_date type="Anticipated">April 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 20, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Week</target_duration>
    <primary_outcome>
      <measure>sensitivity, specificity and accuracy</measure>
      <time_frame>One Year</time_frame>
      <description>sensitivity, specificity and accuracy of pancreatic cystic fluid glucose level with comparison to fluid CEA levels, morey's biopsy result and surgical findings.</description>
    </primary_outcome>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Pancreatic Cyst Fluid</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>EUS</intervention_name>
      <description>EUS examination and cystic fluid will be aspirated for analysis, including cystic fluid Glucose, CEA, amylase. Morey's biopsy will be done in the cases feasible for biopsy.</description>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        cystic fluid glucose level&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Participants with pancreatic cyst of size &gt;2 cm, seen on radiological image, having no&#xD;
          contraindication for endoscopic ultrasound and has not suffered from pancreatitis within&#xD;
          last 3 months) coming to OPD/admitted in ward in AIG Hospital , Hyderabad satisfying&#xD;
          inclusion and exclusion criteria after informed consent, will be included.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients (between 18 to 60 years of age)&#xD;
  &#xD;
            -  Pancreatic cyst of size &gt;2 cm noted on radiological imaging&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient's age &lt;16yrs or &gt;80 yrs.&#xD;
  &#xD;
            -  Prior history of pancreatitis (within 3 months)&#xD;
  &#xD;
            -  Pregnant female&#xD;
  &#xD;
            -  Unfit for endoscopic ultrasound&#xD;
  &#xD;
            -  Not wiling for consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Minutes</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mona Aggarwal, MD, DM</last_name>
      <phone>8851352374</phone>
      <phone_ext>+91</phone_ext>
      <email>drmona.11191@gmail.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cysts</mesh_term>
      <mesh_term>Pancreatic Cyst</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/NCT05962723
  org study id: Pancreatic cyst glucose 1
  nct id: NCT05962723
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  All participants undergoing radiological imaging and found to have pancreatic cyst of size >
        2cm will be subjected to EUS (Endoscopic ultrasound) examination and cystic fluid will be
        aspirated for analysis, including cystic fluid Glucose, CEA, amylase. Morey's biopsy will be
        done in the cases feasible for biopsy. The sensitivity and specificity of cystic fluid
        glucose level will be analysed taking CEA (carcinoembryonic antigen) level with EUS findings,
        amylase level as gold standard for diagnosis, in cases with no surgical management.
  Pancreatic cystic lesion prevalence noted to be increased dramatically in last few decades.
        Earlier record showed the prevalence rate of 2.4-2.6% with magnetic resonance imaging (MRI),
        though sometimes reaching 13.5%.Recent study showed prevalence of pancreatic cysts to be 49%.
        Most of the pancreatic cyst are benign and require conservative management and regular
        evaluation only. Malignant cystic lesion on the other hand require immediate attention and
        surgical excision in most of cases. Thus, diagnosis of pre-malignant & malignant pancreatic
        cyst are essential, to predict the prognosis and decide further management.
  
        Most widely accepted biochemical test for preoperative differentiation of mucinous from
        benign pancreatic cysts is cystic fluid carcinoembryonic antigen (CEA). CEA with cutoff value
        of 192 ng/ml has sensitivity, specifivcity and accuracy of 75%, 84% & 79% respectively. This
        is expensive and requires a longer duration for obtaining the results. Few recent studies
        proposed the role of cystic fluid glucose level in the diagnosis of malignant cyst.
  observational model: Cohort
  time perspective: Prospective
  measure: sensitivity, specificity and accuracy
  time frame: One Year
  description: sensitivity, specificity and accuracy of pancreatic cystic fluid glucose level with comparison to fluid CEA levels, morey's biopsy result and surgical findings.
  intervention type: Procedure
  intervention name: EUS
  description: EUS examination and cystic fluid will be aspirated for analysis, including cystic fluid Glucose, CEA, amylase. Morey's biopsy will be done in the cases feasible for biopsy.
  cystic fluid glucose level
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Minutes
  maximum age: 60 Years
  healthy volunteers: No
  last name: Mona Aggarwal, MD, DM
  phone: 8851352374
  phone ext: +91
  email: drmona.11191@gmail.com
  responsible party type: Sponsor
  mesh term: Cysts
  mesh term: Pancreatic Cyst
  sharing ipd: No