<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/NCT03279653</url>
  </required_header>
  <id_info>
    <org_study_id>p-exocrine-insufficiency</org_study_id>
    <nct_id>NCT03279653</nct_id>
  </id_info>
  <brief_title>Pancreatic Exocrine Insufficiency After Bariatric Surgery</brief_title>
  <official_title>Effect of Sleeve Gastrectomy on Pancreatic Exocrine Insufficiency.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Umraniye Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Umraniye Education and Research Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Main proposed benefit of sleeve gastrectomy is loss of ghrelin secreting tissue. Some studies&#xD;
      express that ghrelin augment pancreatic regeneration. Therefore we hypothesized that with&#xD;
      sleeve gastrectomy it may result with pancreatic insufficiency.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mechanism of weight loss differs in bariatric surgery according to type of surgery.&#xD;
&#xD;
      With sleeve gastrectomy which has restrictive mechanism, ghrelin excretion decreases, and&#xD;
      this condition is attributed as an additional mechanism in weight loss.&#xD;
&#xD;
      Ghrelin effects pancreatic regeneration, and loss of ghrelin may result with pancreatic&#xD;
      insufficiency. Therefore we aimed to deteremine this association.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pancreatic excorine enzyme difference</measure>
    <time_frame>post operative 3 months</time_frame>
    <description>Effect of operation on pancreatic excorine enzyme</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Obesity, Morbid</condition>
  <condition>Pancreatic Insufficiency</condition>
  <arm_group>
    <arm_group_label>SleeveGastrectomy</arm_group_label>
    <description>Sleeve Gastrectomy will be performed. Preoperative and Postoperative pancreatic enzyme sufficiency (with steatocrit or fecal elastase) will be compared.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SleeveGastrectomy</intervention_name>
    <description>Preoperative enzyme test before and after sleeve gastrectomy. Sleeve Gastrectomy will be performed. Preoperative (in one month) and Postoperative (after 3 months) pancreatic enzyme sufficiency (with steatocrit or fecal elastase) will be compared.</description>
    <arm_group_label>SleeveGastrectomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are eligible for bariatric surgery with NIH criteria and American Society of&#xD;
        Anesthesiologists (ASA)-Physical Status Classification System.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients underwent bariatric surgery (Sleeve gastrectomy) after concordonce with NIH&#xD;
        criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Additional operations to sleeve gastrectomy like duodenal switch. Other bariatric&#xD;
        operations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fatih Basak, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Health Science, Umraniye Education and Research Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fatih Basak, MD</last_name>
    <phone>(+0216 6321818</phone>
    <email>fatihbasak@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Umraniye Education and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Ümraniye</state>
        <zip>34000</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fatih Basak</last_name>
      <phone>5055034571</phone>
      <email>fatihbasak@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Umraniye Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Fatih Basak</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Exocrine Pancreatic Insufficiency</mesh_term>
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03279653
org study id: p-exocrine-insufficiency
nct id: NCT03279653
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Main proposed benefit of sleeve gastrectomy is loss of ghrelin secreting tissue. Some studies
      express that ghrelin augment pancreatic regeneration. Therefore we hypothesized that with
      sleeve gastrectomy it may result with pancreatic insufficiency.
Mechanism of weight loss differs in bariatric surgery according to type of surgery.

      With sleeve gastrectomy which has restrictive mechanism, ghrelin excretion decreases, and
      this condition is attributed as an additional mechanism in weight loss.

      Ghrelin effects pancreatic regeneration, and loss of ghrelin may result with pancreatic
      insufficiency. Therefore we aimed to deteremine this association.
observational model: Cohort
time perspective: Prospective
measure: Pancreatic excorine enzyme difference
time frame: post operative 3 months
description: Effect of operation on pancreatic excorine enzyme
arm group label: SleeveGastrectomy
description: Sleeve Gastrectomy will be performed. Preoperative and Postoperative pancreatic enzyme sufficiency (with steatocrit or fecal elastase) will be compared.
intervention type: Procedure
intervention name: SleeveGastrectomy
description: Preoperative enzyme test before and after sleeve gastrectomy. Sleeve Gastrectomy will be performed. Preoperative (in one month) and Postoperative (after 3 months) pancreatic enzyme sufficiency (with steatocrit or fecal elastase) will be compared.
arm group label: SleeveGastrectomy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fatih Basak, MD
role: Principal Investigator
affiliation: University of Health Science, Umraniye Education and Research Hospital
last name: Fatih Basak, MD
phone: (+0216 6321818
email: fatihbasak@gmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Umraniye Education and Research Hospital
investigator full name: Fatih Basak
investigator title: M.D.
mesh term: Exocrine Pancreatic Insufficiency
mesh term: Obesity, Morbid
sharing ipd: No