<?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>IRCT20221026056313N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-24</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy and safety of primary Needle Knife Fistulotomy in patients undergoing ERCP with a long papilla</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy and safety of primary Needle Knife Fistulotomy in patients undergoing ERCP with a long papilla: A single blind randomized prospective study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>181</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70551</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are assigned to two groups using the random block method. The number of blocks will be 4 and in each block three patients will be included in the study order. Random allocation of blocks of patients to two treatment groups will be done through Sealed Envelope online software. The randomized list of blocks is placed in sealed envelopes and will be provided to the endoscopist on a daily basis, Blinding description: The study will be done in a blind way. The evaluator does not know how to assign patients to the group in order to prevent misuse in measuring the results of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>bile duct disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: In the first group, the bile ducts of the patients will be cannulated with a standard technique. In this technique, the guidewire enters the bile duct through the papilla. Patients will undergo ERCP in one session, and its duration will be between 20 and 60 minutes, depending on the difficulty of cannulation. Intervention 2: Intervention group: In the second group, entry into the bile duct will be done with the basic needle-knife technique. In this technique, first an incision is made above the papilla hole, and then the guidewire will enter the bile duct through this incision. Patients will undergo ERCP in one session, and its duration will be between 20 and 60 minutes depending on the difficulty of cannulation.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehrnoosh alizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yemen St., Arabi St., Taleghani Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717413</zip>
        <telephone>+98 21 2243 2560</telephone>
        <email>mehrnoosh_alizadeh@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yemen St., Arabi St., Taleghani Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717413</zip>
        <telephone>+98 21 2243 2560</telephone>
        <email>amirsadeghimd@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People over 18 years old
Patients with acute pancreatitis
Patients with gallstones
ultrasound findings (CBD dilatation) that indicate CBD stone and CBD obstruction.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Age less than 18 years
pregnancy
Contrast sensitivity
History of previous sphincterectomy
Refusal to give informed written consent
Gastrojejunostomy
Patients with severe coagulopathy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K83.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obstruction of bile duct</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: In the first group, the bile ducts of the patients will be cannulated with a standard technique. In this technique, the guidewire enters the bile duct through the papilla. Patients will undergo ERCP in one session, and its duration will be between 20 and 60 minutes, depending on the difficulty of cannulation.</i_keyword>
      <i_keyword>Intervention group: In the second group, entry into the bile duct will be done with the basic needle-knife technique. In this technique, first an incision is made above the papilla hole, and then the guidewire will enter the bile duct through this incision. Patients will undergo ERCP in one session, and its duration will be between 20 and 60 minutes depending on the difficulty of cannulation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Success rate of bile duct cannulation. Timepoint: At the time of cannulation by the endoscopist. Method of measurement: Visual diagnosis of the endoscopist by observing the cannulation process on the monitor.</prim_outcome>
      <prim_outcome>Post ERCP complication. Timepoint: During or after the procedure. Method of measurement: Clinical evidence and laboratory tests of bleeding, perforation, pancreatitis.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body temperature. Timepoint: 4 hours after the completion of the procedure. Method of measurement: thermometer.</sec_outcome>
      <sec_outcome>Amylas. Timepoint: before the procedure and 3 hours after the procedure. Method of measurement: blood test for investigation of Amylas level.</sec_outcome>
      <sec_outcome>Lipas. Timepoint: before the procedure and 3 hours after the procedure. Method of measurement: blood test for investigation of lipas level.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-03</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Yemen St., Shahid Arabi St., Ayatollah Taleghani Hospital Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
