<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/NCT04494282</url>
  </required_header>
  <id_info>
    <org_study_id>INCMNSZ</org_study_id>
    <nct_id>NCT04494282</nct_id>
  </id_info>
  <brief_title>The Economic Impact of the Pancreatography in the Endoscopic Treatment of Pancreatic Pseudocysts</brief_title>
  <official_title>The Economic Impact of the Pancreatography in the Endoscopic Treatment of Pancreatic Pseudocysts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</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>
      Pancreatic pseudocysts (PP) present as a complication that occurs in 5-15% of acute&#xD;
      pancreatitis and 26-40% of chronic pancreatitis (1-3). To date the endoscopic drainage with&#xD;
      endoscopic ultrasound (EUS) has replace the surgical treatment due to the similar success and&#xD;
      complication rate but with a lower cost and short hospital stay (4-6). Regarding recurrence,&#xD;
      it is important to know the anatomy of the main pancreatic duct (MPD). For this purpose, the&#xD;
      endoscopic retrograde pancreatography (ERP) has been describe as a useful tool. In fact, many&#xD;
      authors perform it before the endoscopic drainage while others wait several weeks after the&#xD;
      drainage (7-9) with similar technical success (5,8). However, there are no studies that&#xD;
      compare the technical difficulty and the total cost between these two approaches.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      METHODS: Random control trial between two groups. Group 1 the ERP will be performed the same&#xD;
      day of the endoscopic drainage of PP. Group 2 the ERP will be performed 6 weeks after the&#xD;
      endoscopic drainage of PP. Each ERP will be performed by an expert in ERP in patients who&#xD;
      fulfilled the Atlanta criteria for PP. The patients will be enrolled and informed consent&#xD;
      will be explained and signed. In those patients who ERP fails, a second attempt will be&#xD;
      performed 6 weeks after the endoscopic drainage of PP (Group 1) or a magnetic resonance&#xD;
      cholangiopancreatography will be performed (Group 2).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Random control trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The impact of the pancreatography in the endoscopic treatment of pancreatic pseudocysts</measure>
    <time_frame>6 weeks</time_frame>
    <description>Determine the impact of the timing performing an endoscopic pancreatography in relation of the drainage of pancreatic pseudocyst</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Pseudocyst Pancreas</condition>
  <condition>Pancreatic Duct Disorder</condition>
  <arm_group>
    <arm_group_label>Same day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The ERP will be performed the same day of the endoscopic drainage of PP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The ERP will be performed 6 weeks after the endoscopic drainage of PP.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic retrograde pancreatography</intervention_name>
    <description>Endoscopic cannulation of main pancreatic duct</description>
    <arm_group_label>Other day</arm_group_label>
    <arm_group_label>Same day</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pancreatic pseudocyst that fulfilled the Atlanta Classification&#xD;
&#xD;
          2. Symptomatic pancreatic pseudocyst&#xD;
&#xD;
          3. Informed consent obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient unwilling to participate&#xD;
&#xD;
          2. Absence of duration time of the pancreatography procedure in the record&#xD;
&#xD;
          3. Absence of the number of weeks between the drainage and the pancreatography&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>August 10, 2020</last_update_submitted>
  <last_update_submitted_qc>August 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</investigator_affiliation>
    <investigator_full_name>Angela Saúl</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Pancreatic Pseudocyst</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Pseudocyst</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04494282
org study id: INCMNSZ
nct id: NCT04494282
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pancreatic pseudocysts (PP) present as a complication that occurs in 5-15% of acute
      pancreatitis and 26-40% of chronic pancreatitis (1-3). To date the endoscopic drainage with
      endoscopic ultrasound (EUS) has replace the surgical treatment due to the similar success and
      complication rate but with a lower cost and short hospital stay (4-6). Regarding recurrence,
      it is important to know the anatomy of the main pancreatic duct (MPD). For this purpose, the
      endoscopic retrograde pancreatography (ERP) has been describe as a useful tool. In fact, many
      authors perform it before the endoscopic drainage while others wait several weeks after the
      drainage (7-9) with similar technical success (5,8). However, there are no studies that
      compare the technical difficulty and the total cost between these two approaches.
METHODS: Random control trial between two groups. Group 1 the ERP will be performed the same
      day of the endoscopic drainage of PP. Group 2 the ERP will be performed 6 weeks after the
      endoscopic drainage of PP. Each ERP will be performed by an expert in ERP in patients who
      fulfilled the Atlanta criteria for PP. The patients will be enrolled and informed consent
      will be explained and signed. In those patients who ERP fails, a second attempt will be
      performed 6 weeks after the endoscopic drainage of PP (Group 1) or a magnetic resonance
      cholangiopancreatography will be performed (Group 2).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Random control trial
primary purpose: Treatment
masking: Single (Participant)
measure: The impact of the pancreatography in the endoscopic treatment of pancreatic pseudocysts
time frame: 6 weeks
description: Determine the impact of the timing performing an endoscopic pancreatography in relation of the drainage of pancreatic pseudocyst
arm group label: Same day
arm group type: Active Comparator
description: The ERP will be performed the same day of the endoscopic drainage of PP
arm group label: Other day
arm group type: Active Comparator
description: The ERP will be performed 6 weeks after the endoscopic drainage of PP.
intervention type: Procedure
intervention name: Endoscopic retrograde pancreatography
description: Endoscopic cannulation of main pancreatic duct
arm group label: Other day
arm group label: Same day
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
investigator full name: Angela Saúl
investigator title: Principal investigator
mesh term: Pancreatic Pseudocyst