<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/NCT04401722</url>
  </required_header>
  <id_info>
    <org_study_id>PD in high altitude</org_study_id>
    <nct_id>NCT04401722</nct_id>
  </id_info>
  <brief_title>Clinical Impact of Altitude Level on Surgical Outcomes of Pancreaticoduodenectomy</brief_title>
  <acronym>PD</acronym>
  <official_title>Clinical Impact of Altitude Level on Surgical Outcomes of Pancreaticoduodenectomy for Periampullary Tumour (Multicenter Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Very few papers examine the effect of living at high altitudes on surgical results of major&#xD;
      operations. This research is designed to determine the surgical outcomes of PD for&#xD;
      periampullary tumour in high altitudes and normal altitudes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many recent studies have suggested multiple risk factors affecting postoperative surgical&#xD;
      outcomes of PD; THE research is designed to determine the surgical outcomes of PD for&#xD;
      periampullary tumour in high altitudes and normal altitude.&#xD;
&#xD;
      it is a multicenter study Aseer central hospital, Saudia and from Egypt two centers Mansoura&#xD;
      university and el Menia university&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">April 25, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>it is a multicenter study Aseer centeral hospital, saudia and from Egypt two centers mansoura university and el menia university The patients distributed into two groups group I (G1) PD underwent in the area at the level of the sea, normal altitude region, and group II (G2) PD underwent in high altitude region.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>OUTCOME ASESSOR</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>the overall postoperative complications</measure>
    <time_frame>30 DAYS</time_frame>
    <description>the overall postoperative complications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>blood loss</measure>
    <time_frame>INTRAOPERATIVE</time_frame>
    <description>blood loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary embolism (PE)</measure>
    <time_frame>30 days</time_frame>
    <description>Pulmonary embolism (PE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hospital mortality</measure>
    <time_frame>30 days</time_frame>
    <description>death within 30 days of operation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Periampullary Cancer</condition>
  <arm_group>
    <arm_group_label>PD in normal altitude</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PD underwent in the area at the level of the sea, normal altitude region</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PD in high altitude region.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PD underwent in high altitude region.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PANCREATICODUDENECTOMY</intervention_name>
    <description>dissection and removal of periampulary tumour with 3 reconstruction PJ, HJ, and GJ</description>
    <arm_group_label>PD in high altitude region.</arm_group_label>
    <arm_group_label>PD in normal altitude</arm_group_label>
    <other_name>Whippl,s operation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  periampulary tumour&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  liver cirrhosis,&#xD;
&#xD;
          -  PG,&#xD;
&#xD;
          -  advanced tumour,&#xD;
&#xD;
          -  vascular resection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ayman E Nakeeb, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mansoura University, Gastrointestinal Surgery Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mahmoud Abd El Wahab</name>
      <address>
        <city>Mansoura</city>
        <zip>356111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>http://www.mans.edu.eg/en/</url>
    <description>Mansoura university</description>
  </link>
  <reference>
    <citation>Dutta V, Singh R, Kumar S, Aggarwal N, Hari Kumar KVS. Profile of pulmonary embolism in service personnel posted at high altitude area. Indian Heart J. 2018 May-Jun;70(3):427-429. doi: 10.1016/j.ihj.2017.08.002. Epub 2017 Aug 18.</citation>
    <PMID>29961462</PMID>
  </reference>
  <results_reference>
    <citation>El Nakeeb A, Attia M, El Sorogy M, Ezzat H, Shehta A, Salem A, El Gawad MA, Hamed H, Allah TA, El-Geidi AA, Fathy O, El Hefnawy E, Zaghloul A. Laparoscopic Pancreaticodudenectomy for Periampullary Tumor: Should it be a Routine? A Propensity Score-matched Study. Surg Laparosc Endosc Percutan Tech. 2020 Feb;30(1):7-13. doi: 10.1097/SLE.0000000000000715.</citation>
    <PMID>31461084</PMID>
  </results_reference>
  <results_reference>
    <citation>El Nakeeb A, El Sorogy M, Hamed H, Said R, Elrefai M, Ezzat H, Askar W, Elsabbagh AM. Biliary leakage following pancreaticoduodenectomy: Prevalence, risk factors and management. Hepatobiliary Pancreat Dis Int. 2019 Feb;18(1):67-72. doi: 10.1016/j.hbpd.2018.10.005. Epub 2018 Oct 28.</citation>
    <PMID>30413347</PMID>
  </results_reference>
  <results_reference>
    <citation>Prabhakar A, Chatterjee T, Bajaj N, Tyagi T, Sahu A, Gupta N, Kumari B, Nair V, Kumar B, Ashraf MZ. Venous thrombosis at altitude presents with distinct biochemical profiles: a comparative study from the Himalayas to the plains. Blood Adv. 2019 Nov 26;3(22):3713-3723. doi: 10.1182/bloodadvances.2018024554.</citation>
    <PMID>31765479</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>June 6, 2020</last_update_submitted>
  <last_update_submitted_qc>June 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Ayman El Nakeeb</investigator_full_name>
    <investigator_title>gastrointestinal surgical center, Mansoura University</investigator_title>
  </responsible_party>
  <keyword>pancreaticodudenctomy</keyword>
  <keyword>POPF</keyword>
  <keyword>HIGH ALTITUDE</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>it will be available for other researchers</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>6 month</ipd_time_frame>
    <ipd_access_criteria>elnakeebayman@yahoo.com</ipd_access_criteria>
    <ipd_url>http://www.mans.edu.eg/en/</ipd_url>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>Ayman El Nakeeb</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>http://www.mans.edu.eg/en/</doc_url>
      <doc_comment>through elnakeebayman@yahoo.com</doc_comment>
    </study_doc>
  </study_docs>
  <!-- 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/NCT04401722
org study id: PD in high altitude
nct id: NCT04401722
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Very few papers examine the effect of living at high altitudes on surgical results of major
      operations. This research is designed to determine the surgical outcomes of PD for
      periampullary tumour in high altitudes and normal altitudes.
Many recent studies have suggested multiple risk factors affecting postoperative surgical
      outcomes of PD; THE research is designed to determine the surgical outcomes of PD for
      periampullary tumour in high altitudes and normal altitude.

      it is a multicenter study Aseer central hospital, Saudia and from Egypt two centers Mansoura
      university and el Menia university
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: it is a multicenter study Aseer centeral hospital, saudia and from Egypt two centers mansoura university and el menia university The patients distributed into two groups group I (G1) PD underwent in the area at the level of the sea, normal altitude region, and group II (G2) PD underwent in high altitude region.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: OUTCOME ASESSOR
measure: the overall postoperative complications
time frame: 30 DAYS
description: the overall postoperative complications
measure: blood loss
time frame: INTRAOPERATIVE
description: blood loss
measure: Pulmonary embolism (PE)
time frame: 30 days
description: Pulmonary embolism (PE)
measure: hospital mortality
time frame: 30 days
description: death within 30 days of operation
arm group label: PD in normal altitude
arm group type: Active Comparator
description: PD underwent in the area at the level of the sea, normal altitude region
arm group label: PD in high altitude region.
arm group type: Active Comparator
description: PD underwent in high altitude region.
intervention type: Procedure
intervention name: PANCREATICODUDENECTOMY
description: dissection and removal of periampulary tumour with 3 reconstruction PJ, HJ, and GJ
arm group label: PD in high altitude region.
arm group label: PD in normal altitude
other name: Whippl,s operation
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ayman E Nakeeb, MD
role: Principal Investigator
affiliation: Mansoura University, Gastrointestinal Surgery Center
facility: 
country: Egypt
url: http://www.mans.edu.eg/en/
description: Mansoura university
citation: Dutta V, Singh R, Kumar S, Aggarwal N, Hari Kumar KVS. Profile of pulmonary embolism in service personnel posted at high altitude area. Indian Heart J. 2018 May-Jun;70(3):427-429. doi: 10.1016/j.ihj.2017.08.002. Epub 2017 Aug 18.
PMID: 29961462
citation: El Nakeeb A, Attia M, El Sorogy M, Ezzat H, Shehta A, Salem A, El Gawad MA, Hamed H, Allah TA, El-Geidi AA, Fathy O, El Hefnawy E, Zaghloul A. Laparoscopic Pancreaticodudenectomy for Periampullary Tumor: Should it be a Routine? A Propensity Score-matched Study. Surg Laparosc Endosc Percutan Tech. 2020 Feb;30(1):7-13. doi: 10.1097/SLE.0000000000000715.
PMID: 31461084
citation: El Nakeeb A, El Sorogy M, Hamed H, Said R, Elrefai M, Ezzat H, Askar W, Elsabbagh AM. Biliary leakage following pancreaticoduodenectomy: Prevalence, risk factors and management. Hepatobiliary Pancreat Dis Int. 2019 Feb;18(1):67-72. doi: 10.1016/j.hbpd.2018.10.005. Epub 2018 Oct 28.
PMID: 30413347
citation: Prabhakar A, Chatterjee T, Bajaj N, Tyagi T, Sahu A, Gupta N, Kumari B, Nair V, Kumar B, Ashraf MZ. Venous thrombosis at altitude presents with distinct biochemical profiles: a comparative study from the Himalayas to the plains. Blood Adv. 2019 Nov 26;3(22):3713-3723. doi: 10.1182/bloodadvances.2018024554.
PMID: 31765479
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Ayman El Nakeeb
investigator title: gastrointestinal surgical center, Mansoura University
sharing ipd: Yes
ipd description: it will be available for other researchers
ipd info type: Study Protocol
ipd time frame: 6 month
ipd access criteria: elnakeebayman@yahoo.com
ipd url: http://www.mans.edu.eg/en/
study doc: 