<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT201201098635N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-05-09</date_registration>
      <primary_sponsor>Research Deputy of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of EUS-guided alcohol ablation effectiveness in treatment of insolinoma</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of EUS-guided alcohol ablation effectiveness in treatment of insolinoma</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9128</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>1</phase>
      <hc_freetext>insulinoma.</hc_freetext>
      <i_freetext>Intervention 1: After localizing the site of the tumor by EUS, fine needle aspiration of the tumor  will be performed for cytological evaluation. At least three passes of FNA with a 22-guage needle (COOK) will be taken. The samples will be placed into 70% ethanol and sent for cell block preparation and cytological evaluation. &#13;
Then, a total of 6 ml of 95% ethanol will be injected during the same session using linear array echo-endoscope guidance. The patients will be hospitalized for 48 hours. &#13;
The patients will be received dextrose 10% (1000 ml every 8 hours) during the first 24 hours after alcohol injection. &#13;
Periodic visits of the patient will be performed during the hospitalization. The patients will be monitored for any symptoms (e.g. abdominal pain, nausea, vomiting, etc.). Serum levels of amylase and lipase will be checked at hour 12, hour 24 and hour 48 post-procedure. &#13;
Outcome measures:&#13;
•Fasting plasma glucose level at day 0 (before the procedure), day 1, month 1, month 3, month 6, month 12 post-procedure&#13;
•EUS of the pancreas to evaluate tumor remission at month 3, and month 12 post-procedure. Intervention 2: Control group: the patients with insulinoma treating by surgery.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Neda rabiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Resaerch center of Gastroentrology and liver diseases, Firoozgar hospital, Beh afarin st, Vali asr sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8214 1711</telephone>
        <email>Neda.rabiei@gmail.com</email>
        <affiliation>Firoozgar hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Mohammadnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Northern Karegar st, Shariati hospital.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8822 0000</telephone>
        <email>mehdi.nejad@gmail.com</email>
        <affiliation>Shariati hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
•Biochemically proven solitary insulinoma&#13;
•Ages between 18 and 80 years old&#13;
Exclusion criteria:&#13;
•Insulinoma size of 2 cm or more&#13;
•Presence of lymph node, or vascular involvement of the tumor in EUS or spiral CT scan&#13;
•Presence of liver or other distant metastases in the spiral CT scan &#13;
•Presence of MEN-1 syndrome&#13;
•Presence of multiple insulinomas&#13;
•Inability to localize the tumor by EUS&#13;
•Unwilling to assign inform consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C25.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pancreas, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After localizing the site of the tumor by EUS, fine needle aspiration of the tumor  will be performed for cytological evaluation. At least three passes of FNA with a 22-guage needle (COOK) will be taken. The samples will be placed into 70% ethanol and sent for cell block preparation and cytological evaluation. &#13;
Then, a total of 6 ml of 95% ethanol will be injected during the same session using linear array echo-endoscope guidance. The patients will be hospitalized for 48 hours. &#13;
The patients will be received dextrose 10% (1000 ml every 8 hours) during the first 24 hours after alcohol injection. &#13;
Periodic visits of the patient will be performed during the hospitalization. The patients will be monitored for any symptoms (e.g. abdominal pain, nausea, vomiting, etc.). Serum levels of amylase and lipase will be checked at hour 12, hour 24 and hour 48 post-procedure. &#13;
Outcome measures:&#13;
•Fasting plasma glucose level at day 0 (before the procedure), day 1, month 1, month 3, month 6, month 12 post-procedure&#13;
•EUS of the pancreas to evaluate tumor remission at month 3, and month 12 post-procedure</i_keyword>
      <i_keyword>Control group: the patients with insulinoma treating by surgery</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The effectivenrss of the process. Timepoint: In the first and third month after treatment, BS level, and  also in the third month the size of tumor would be measured and regiter by (EUS) method. Method of measurement: According to check list.</prim_outcome>
      <prim_outcome>Serum amylase. Timepoint: 12, 24 and48 hours post(EUS). Method of measurement: Patients blood sampling.</prim_outcome>
      <prim_outcome>Serum lipase. Timepoint: 12, 24 and 48 hours post(EUS). Method of measurement: Patient's blood sampling.</prim_outcome>
      <prim_outcome>The procedure's time. Timepoint: During sonography and alcohol injection. Method of measurement: According to endoscopist's report.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Complications. Timepoint: During first 48 hours of admission. Method of measurement: According to physical exams and tests.</sec_outcome>
      <sec_outcome>Admission time. Timepoint: The average of the patient's  spending days while the procedure untill discharging from the hospital. Method of measurement: According to the file.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Research Deputy of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-05-02</approval_date>
        <contact_name>Tehran university of medical sciences</contact_name>
        <contact_address>Tehran university of medical sciences, Ghods ave, Keshavarz boulvard, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
