<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/NCT04487002</url>
  </required_header>
  <id_info>
    <org_study_id>441/11</org_study_id>
    <nct_id>NCT04487002</nct_id>
  </id_info>
  <brief_title>Outcome After Surgical Resection of Gastrointestinal Stromal Tumors (GIST) in the Second Part of Duodenum</brief_title>
  <acronym>GIST</acronym>
  <official_title>Outcome After Surgical Treatment of Gastrointestinal Stromal Tumors in the Second Part of Duodenum: Is Localized Resection Appropriate?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria University</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>
      it is hypothesized that long term outcomes of localized resection of GIST tumors located in&#xD;
      the second part of the duodenum are comparable to those of the traditional treatment by&#xD;
      radical resection of the head o pancreas and the entire duodenum&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the Medical records of patient with second part duodenal GIST were reviewed retrospectively&#xD;
      for symptoms, clinical examination, preoperative workup including standard imaging by&#xD;
      multi-slice computed tomography (CT) of abdomen and pelvis with oral and intravenous&#xD;
      contrast. Endoscopic ultrasound was routinely perfumed to assess the depth of tumor invasion&#xD;
      (T-stage) and to obtain a tissue sample by fine needle aspiration cytology (FNAC). Definitive&#xD;
      diagnosis was based on CT images and post-operative pathology report.&#xD;
&#xD;
      Patients were subjected to curative localized resection with free margins by frozen section&#xD;
      examination or pancreaticoduodenectomy (PD) if the tumor was invading the major duodenal&#xD;
      papilla.&#xD;
&#xD;
      Localized duodenal resection was performed by one of two techniques: The first one was&#xD;
      excision of part of the wall (wedge resection). Reconstruction was performed either by&#xD;
      primary closure without tension, provided that adequate lumen is preserved, or by side to&#xD;
      side roux-en-Y duodenojejunostomy (DJ) if there was tension on the edges of the duodenal&#xD;
      defect. The second technique was employed in case of larger size tumors and entailed excision&#xD;
      of D2 (segmental duodenectomy) to be followed by anastomosis (side to side roux-en-Y DJ or&#xD;
      end-to-end DJ). Great care to avoid tumor rupture was emphasized in all operations. Standard&#xD;
      lymph node dissection was not performed.&#xD;
&#xD;
      Pathologic data (tumor location, size, margins, and mitoses per 50 high-power fields [HPF])&#xD;
      and immunohistochemical analysis were collected and tumors classified into very low, low,&#xD;
      moderate and high risk based on Miettinen classification that also incorporates tumor size.&#xD;
&#xD;
      All patients (those who underwent localized resection with safety margin and those who&#xD;
      underwent PD) were followed up and re-evaluated at one, three, six and twelve months then&#xD;
      once per year for a total follow-up period of 3 years. Contrast-enhanced multi-slice CT&#xD;
      abdomen/pelvis was performed after 6 months then yearly for detection of recurrence.&#xD;
&#xD;
      Using PASS program version 20, the minimum sample size required was 45 patients with duodenal&#xD;
      GIST using 3% local recurrence rate and 5% error at 5% level of significance and 80% power.&#xD;
      Data were analyzed using IBM-SPSS software package version 20. Qualitative variables were&#xD;
      summarized using numbers and percent. Quantitative variables were summarized using mean and&#xD;
      standard deviation (SD) as data was normally distributed by kolmogrov-smirnov test. Survival&#xD;
      analysis was done using life tables, log-rank test and Kaplan Meier's curve. All statistical&#xD;
      analysis was conducted at 5% level of significance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>survival</measure>
    <time_frame>3 years</time_frame>
    <description>Survival was calculated from the date of surgery to the time of death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>recurrence rate</measure>
    <time_frame>3 years</time_frame>
    <description>. Contrast-enhanced multi-slice CT abdomen/pelvis was performed after 6 months then yearly for detection of recurrence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>post-operative complications</measure>
    <time_frame>one month</time_frame>
    <description>leak, wound infection, chest infection</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Gastrointestinal Stromal Tumor of Duodenum</condition>
  <arm_group>
    <arm_group_label>group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>underwent localized resection</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>surgical resection</intervention_name>
    <arm_group_label>group A</arm_group_label>
    <other_name>localized resection or pancreaticoduodenectomy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with second part duodenal GIST&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  metastatic, irresectible and unfitness for surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wael N Abdelsalam, doctor</last_name>
    <role>Study Director</role>
    <affiliation>dean of faculty</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Alexandria</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>Hani Alhadad</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>Gastrointestinal stromal tumor of duodenum; localized resection; survival</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Stromal Tumors</mesh_term>
    <mesh_term>Duodenal Neoplasms</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/NCT04487002
org study id: 441/11
nct id: NCT04487002
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
it is hypothesized that long term outcomes of localized resection of GIST tumors located in
      the second part of the duodenum are comparable to those of the traditional treatment by
      radical resection of the head o pancreas and the entire duodenum
the Medical records of patient with second part duodenal GIST were reviewed retrospectively
      for symptoms, clinical examination, preoperative workup including standard imaging by
      multi-slice computed tomography (CT) of abdomen and pelvis with oral and intravenous
      contrast. Endoscopic ultrasound was routinely perfumed to assess the depth of tumor invasion
      (T-stage) and to obtain a tissue sample by fine needle aspiration cytology (FNAC). Definitive
      diagnosis was based on CT images and post-operative pathology report.

      Patients were subjected to curative localized resection with free margins by frozen section
      examination or pancreaticoduodenectomy (PD) if the tumor was invading the major duodenal
      papilla.

      Localized duodenal resection was performed by one of two techniques: The first one was
      excision of part of the wall (wedge resection). Reconstruction was performed either by
      primary closure without tension, provided that adequate lumen is preserved, or by side to
      side roux-en-Y duodenojejunostomy (DJ) if there was tension on the edges of the duodenal
      defect. The second technique was employed in case of larger size tumors and entailed excision
      of D2 (segmental duodenectomy) to be followed by anastomosis (side to side roux-en-Y DJ or
      end-to-end DJ). Great care to avoid tumor rupture was emphasized in all operations. Standard
      lymph node dissection was not performed.

      Pathologic data (tumor location, size, margins, and mitoses per 50 high-power fields [HPF])
      and immunohistochemical analysis were collected and tumors classified into very low, low,
      moderate and high risk based on Miettinen classification that also incorporates tumor size.

      All patients (those who underwent localized resection with safety margin and those who
      underwent PD) were followed up and re-evaluated at one, three, six and twelve months then
      once per year for a total follow-up period of 3 years. Contrast-enhanced multi-slice CT
      abdomen/pelvis was performed after 6 months then yearly for detection of recurrence.

      Using PASS program version 20, the minimum sample size required was 45 patients with duodenal
      GIST using 3% local recurrence rate and 5% error at 5% level of significance and 80% power.
      Data were analyzed using IBM-SPSS software package version 20. Qualitative variables were
      summarized using numbers and percent. Quantitative variables were summarized using mean and
      standard deviation (SD) as data was normally distributed by kolmogrov-smirnov test. Survival
      analysis was done using life tables, log-rank test and Kaplan Meier's curve. All statistical
      analysis was conducted at 5% level of significance.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: survival
time frame: 3 years
description: Survival was calculated from the date of surgery to the time of death
measure: recurrence rate
time frame: 3 years
description: . Contrast-enhanced multi-slice CT abdomen/pelvis was performed after 6 months then yearly for detection of recurrence
measure: post-operative complications
time frame: one month
description: leak, wound infection, chest infection
arm group label: group A
arm group type: Experimental
description: underwent localized resection
intervention type: Procedure
intervention name: surgical resection
arm group label: group A
other name: localized resection or pancreaticoduodenectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Wael N Abdelsalam, doctor
role: Study Director
affiliation: dean of faculty
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Alexandria University
investigator full name: Hani Alhadad
investigator title: assistant professor
mesh term: Gastrointestinal Stromal Tumors
mesh term: Duodenal Neoplasms