<?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>IRCT20080921001264N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-29</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>Role of somatostatin in the incidence of post – ERCP pancreatitis</public_title>
      <acronym></acronym>
      <scientific_title>Assessment the role of somatostatin and indomethacin versus only indomethacin in the incidence of post – ERCP pancreatitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>360</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49015</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this way, using the Block Balanced Randomization method with four blocks and preparing a list of blocks and assigning numbers to them, a list of treatment allocations is prepared and patients are assigned to one of the somatostatin and indomethacin groups or indomethacin group according to the list, Blinding description: Due to the use of numbers to randomly assign patients to treatment groups and the use of quadruple blocks, all patients are coded.
Patients in the intervention group and patients in the control and subspecialty group of gastroenterologists performing ERCP, the laboratory assessing the level of amylase, and the statistical consultant analyzing the data will be unaware of which group the patient belongs to. Evaluation and increase of accuracy and objectivity of clinical results were performed.</study_design>
      <phase>4</phase>
      <hc_freetext>Pancreatitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: somatostatin plus indometacin. Somatostatin 250 μg bolus for 1-2 minutes pre-ERCP Long-term infusion of somatostatin 500μg, started during ERCP and lasted for two hours ‎Indomethacin suppository 100mg pre-ERCP and 100mg post-ERCP. Intervention 2: Control group: Indomethacin alone. For control group, normal saline and indomethacine suppository (100 mg) were administrated before and after ERCP.‎.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All potential data can be shared after people have not been identified

When:
from December 2020

To whom:
all

Conditions:
-

Where to obtain:
To the PI of the study

How to obtain:
research deputy

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Norouzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shast kola</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4918936316</zip>
        <telephone>+98 17 3242 4103</telephone>
        <email>norouzi54@gmail.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Norouzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shast kola</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4918936316</zip>
        <telephone>+98 17 3242 4103</telephone>
        <email>norouzi54@gmail.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with biliary tract problems who refer to 5 Azar Hospital in gorgan to perform ERCP diagnostic-therapeutic method from the beginning of April 2017.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>95 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Previous history of sphincterotomy
history of chronic pancreatitis
acute pancreatitis when visiting
Allergy to somatostatin or NSAIDS</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K85.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute pancreatitis, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: somatostatin plus indometacin. Somatostatin 250 μg bolus for 1-2 minutes pre-ERCP Long-term infusion of somatostatin 500μg, started during ERCP and lasted for two hours ‎Indomethacin suppository 100mg pre-ERCP and 100mg post-ERCP</i_keyword>
      <i_keyword>Control group: Indomethacin alone. For control group, normal saline and indomethacine suppository (100 mg) were administrated before and after ERCP.‎</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pancreatitis. Timepoint: 2 and 18 hours. Method of measurement: serum amylase.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-17</approval_date>
        <contact_name>Ethical committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>Shast kola Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
