<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/NCT04410640</url>
  </required_header>
  <id_info>
    <org_study_id>EGE18-6.134</org_study_id>
    <nct_id>NCT04410640</nct_id>
  </id_info>
  <brief_title>Surgical Planning With Patient-specific Pancreaticobiliary Disease With 3D Models</brief_title>
  <official_title>Ethical Committee at Researches of Ege University</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ege University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ege 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>
      Background: Three-dimensional (3D) printing has been increasingly used in medical&#xD;
      applications with the creation of accurate patient-specific 3D printed models in medical&#xD;
      imaging data. However, research on 3D printing in pancreaticobiliary disease is limited with&#xD;
      lack of studies on validation of model accuracy.&#xD;
&#xD;
      Methods: This is a where general surgery residents, are introduced to 5 distinct&#xD;
      hepatopancreatobiliary disease scenarios to generate a perception and required to compare&#xD;
      their perception level of these cases with computed tomography (CT), 3D images and 1:1 solid&#xD;
      models that the pathology, diverse diagnosis and presurgery diagnosis stages can be&#xD;
      investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      2.1.Research Design This study group are general surgery residents present in Faculty of&#xD;
      Medicine, Ege University (n=19). A quintet with stations composed of normal&#xD;
      pancreaticobiliary anatomy, common bile duct tumor, stony cholecystitis, pancreatic head&#xD;
      cancer and cholelithiasis is assembled for the study. Each station containes CT, 3D-STL&#xD;
      images and 1:1 solid models of cases. Each imaging method (CT, 3D-STL image and 3D solid&#xD;
      model) associated with the scenarios of the quintet is created in the residents of the study.&#xD;
      An explanatory assessment measure is being used as data collection method where the&#xD;
      perception of each imaging method is being investigated based on their effectiveness in&#xD;
      problem identification as well as their efficiency in diverse diagnosis and pre-surgery&#xD;
      organization.&#xD;
&#xD;
      2.2. Selection of the sample cases The patients are chosen among the CT examinations of the&#xD;
      ones who referred to Ege University Faculty of Medicine, Department of General Surgery for&#xD;
      diagnose and treatment between 2016 and 2018. CT archives are screened and 5 eligible&#xD;
      patients (age: 18-62 year) who required hepatopancreatobiliary surgery were selected.&#xD;
      Selection of the cases is based on patients with no previous hepatopancreatobiliary&#xD;
      operation, pathology leading to dilated biliary duct, and whose radiological imaging results&#xD;
      are suitable for modeling. Virtual modeling of pancreaticobiliary pathways of the cases is&#xD;
      performed and clinical histories of each case were created.&#xD;
&#xD;
      2.3. Scenarios As a mutual agreement among the specialists in medical education, general&#xD;
      surgery, anatomy and radiology, 5 cases identified, are elected to be samples for&#xD;
      pancreaticobiliary surgical processes. Having defined these cases, they are further converted&#xD;
      into genuine scenarios fully equipped with a past story, medical analysis results and imaging&#xD;
      procedures.&#xD;
&#xD;
      Scenarios for 5 cases:&#xD;
&#xD;
      Case 1. Case with normal extrahepatic biliary tract with pancreas. Case 2. Choledochal tumor&#xD;
      leading to advanced dilatation and hydropic gallbladder appearance in extrahepatic biliary&#xD;
      tract.&#xD;
&#xD;
      Case 3. Acute cholecystitis characterized with extrahepatic biliary dilatation, hydropic&#xD;
      gallbladder, thickness in gallbladder wall and biliary sludge with multiple millimeter-sized&#xD;
      stones.&#xD;
&#xD;
      Case 4. Pancreatic head cancer with severe dilatation in the pancreatic canal and&#xD;
      extrahepatic biliary tract.&#xD;
&#xD;
      Case 5. Choledocholithiasis characterized with dilatation at the extrahepatic biliary tract&#xD;
      and 7 mm diameter stone at the distal end of the common bile duct.&#xD;
&#xD;
      2.4. Image post-processing and segmentation Original CT images in Digital Imaging and&#xD;
      Communications in Medicine (DICOM) format are converted to a separate workstation with&#xD;
      Analyze 12.0 for post-processing and segmentation. A free 3D slicer (version 4.10.1) is&#xD;
      employed in the process of attaining DICOM output from CT and MRI segments of the patients.&#xD;
      Special attention is paid to the anatomical structures of the biliary tract including left&#xD;
      hepatic duct (LHD), right hepatic duct (RHD), and common hepatic duct (CHD) which are&#xD;
      segmented. The surface condition of the model is enhanced by implementing a softening filter&#xD;
      to the segmented section output. The output is extracted into STL format to enable 3D&#xD;
      printing.&#xD;
&#xD;
      2.5. Creating Life-size Patient-Specific 3D Model 3D printers of Mass Portal Pharaoh xd 20&#xD;
      and Form Labs2 are employed throughout the process of preparing the models for printing.&#xD;
&#xD;
      2.6. Quantitative assessment of model accuracy To ensure the model accuracy, measurements of&#xD;
      the anatomical landmarks are performed and compared at three stages of the model production,&#xD;
      namely, the original CT images, STL file and 3D model. The internal diameter of four&#xD;
      anatomical locations is measured from left to right and from anterior to posterior in the&#xD;
      following landmarks: CHD, LHD, RHD and common bile ducts. .&#xD;
&#xD;
      2.7. Workshop We performed a systematic review to evaluate of bile tree modelization and 3D&#xD;
      printing, as well as the proof of concept of the benefit of 3D solid model in planning&#xD;
      interventions. CT images of a patient diagnosed with dilated extrahepatic ducts are used to&#xD;
      create the patient-specific, 1-1 scale 3D pancreaticobiliary models including five scenarios&#xD;
      as the normal anatomy, common bile duct tumor, stony cholecystitis, pancreatic head cancer&#xD;
      and cholelithiasis. For this purpose, scenarios for each case and a five-station carousel are&#xD;
      based on the research. For each station, a period of 5-10 minutes is given.&#xD;
&#xD;
      2.8. Survey Participants' perception of residency training is evaluated with a multi-entry&#xD;
      survey. In these scenarios, normal pancreaticobiliary organs and cases leading to&#xD;
      extrahepatic biliary tract dilatation such as choledochal tumor, acute stone cholecystitis,&#xD;
      pancreatic head tumor and cholelithiasis are discussed. Assessment forms for the normal&#xD;
      structure of the cases, differential diagnosis and imaging methods in preoperative planning&#xD;
      and the location of the 3D solid model are prepared. The forms are then asked to be filled by&#xD;
      the residents to discover their opinions on all models. The evaluaton is done on a scale of&#xD;
      10, where (01-10) defines 0 = very low and 10 = the highest rank.&#xD;
&#xD;
      2.9. Statistical analysis Analysis will be submitted into SPSS 24.0 for statistical&#xD;
      evaluation mean ± standard deviation format is employed for continuous variables. Any&#xD;
      significant differences in the measurements between the original CT images, 3D-STL images and&#xD;
      the 3D model are studied by using Wilcoxon Signed Test. Wilcoxon Signed Ranks Test is used to&#xD;
      determine any significant differences in the measurements between the original CT images,&#xD;
      3D-STL images and the 3D model. Statistical relevance is stated as a p value of less than&#xD;
      0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 10, 2019</start_date>
  <completion_date type="Actual">January 10, 2020</completion_date>
  <primary_completion_date type="Actual">November 10, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>compare the effectiveness of the solid model with CT screen, 3D-Standard Tessellation Language (STL) image and 1:1 scale model</measure>
    <time_frame>30 minute</time_frame>
    <description>Our aim is to compare the effectiveness of the solid model with CT screen, 3D-Standard Tessellation Language (STL) image and 1:1 scale model in 5 different hepatopancreatobiliary disease scenarios to general surgery residents in terms of recognizing the pathology, differential diagnosis and preoperative preparation stages.</description>
  </primary_outcome>
  <enrollment type="Actual">19</enrollment>
  <condition>Surgical Injury</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>survey</intervention_name>
    <description>Members chosen for this study group are general surgery residents. A quintet with stations composed of normal pancreaticobiliary anatomy, common bile duct tumor, stony cholecystitis, pancreatic head cancer and cholelithiasis was assembled for the study. Each station contained CT, 3D-STL images and 1:1 solid models of cases. Each imaging method associated with the scenarios of the quintet is observed by the residents of the study. An explanatory assessment measure is being used as data collection method where the perception of each imaging method is being evaluated based on their effectiveness in problem identification as well as their efficiency in diverse diagnosis and pre-surgery organization. Participants' perception of residency training was evaluated with a multi-entry survey. The focus of the survey, which was applied by our team was by domains, self determined decision-making, diverse diagnosis, academic scholarship, and scientific appraisal.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Members chosen for this study group are general surgery residents present in Faculty of&#xD;
        Medicine, Ege University&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  normal pancreaticobiliary anatomy case&#xD;
&#xD;
          -  common bile duct tumor case,&#xD;
&#xD;
          -  acute calculous cholecystitis,&#xD;
&#xD;
          -  pancreatic head cancer&#xD;
&#xD;
          -  cholelithiasis&#xD;
&#xD;
          -  general surgery residents present in Faculty of Medicine, Ege University&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hepatic disease&#xD;
&#xD;
          -  General surgery experts&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Muhtar S Ersin, Prof. Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Faculty of Medicine, Ege University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ege University, Faculty of Medicine</name>
      <address>
        <city>Izmir</city>
        <state>Bornova</state>
        <zip>TR-35100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>March 12, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ege University</investigator_affiliation>
    <investigator_full_name>Figen GOVSA</investigator_full_name>
    <investigator_title>Prof. Dr, Senior investigator</investigator_title>
  </responsible_party>
  <keyword>Graduate medical education</keyword>
  <keyword>Personalized medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intraoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Our aim is to compare the effectiveness of the solid model with CTimage, 3Dimage and 3Dmodel in 5 different hepatopancreatobiliary disease scenarios presented to general surgery residents in terms of recognizing the pathology, differential diagnosis and preoperative preparation stages. The focus of the survey applied by our team was on domains, decision-making, diverse diagnosis, scientific appraisal. In these scenarios, normal pancreaticobiliary organs and cases leading to extrahepatic biliary tract dilatation such as choledochal tumor, acute stone cholecystitis, pancreatic head tumor and cholelithiasis were discussed. Perception of the anatomical formation, impact of the procedure to diverse diagnosis, operation arrangement and presurgical preparation assistance are the main criteria in the evaluation of every imaging procedure. Any significant differences in the measurements between the CTimages, 3Dimages and the 3Dmodel were obtained by using Wilcoxon Signed Test.</ipd_description>
  </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/NCT04410640
org study id: EGE18-6.134
nct id: NCT04410640
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background: Three-dimensional (3D) printing has been increasingly used in medical
      applications with the creation of accurate patient-specific 3D printed models in medical
      imaging data. However, research on 3D printing in pancreaticobiliary disease is limited with
      lack of studies on validation of model accuracy.

      Methods: This is a where general surgery residents, are introduced to 5 distinct
      hepatopancreatobiliary disease scenarios to generate a perception and required to compare
      their perception level of these cases with computed tomography (CT), 3D images and 1:1 solid
      models that the pathology, diverse diagnosis and presurgery diagnosis stages can be
      investigated.
2.1.Research Design This study group are general surgery residents present in Faculty of
      Medicine, Ege University (n=19). A quintet with stations composed of normal
      pancreaticobiliary anatomy, common bile duct tumor, stony cholecystitis, pancreatic head
      cancer and cholelithiasis is assembled for the study. Each station containes CT, 3D-STL
      images and 1:1 solid models of cases. Each imaging method (CT, 3D-STL image and 3D solid
      model) associated with the scenarios of the quintet is created in the residents of the study.
      An explanatory assessment measure is being used as data collection method where the
      perception of each imaging method is being investigated based on their effectiveness in
      problem identification as well as their efficiency in diverse diagnosis and pre-surgery
      organization.

      2.2. Selection of the sample cases The patients are chosen among the CT examinations of the
      ones who referred to Ege University Faculty of Medicine, Department of General Surgery for
      diagnose and treatment between 2016 and 2018. CT archives are screened and 5 eligible
      patients (age: 18-62 year) who required hepatopancreatobiliary surgery were selected.
      Selection of the cases is based on patients with no previous hepatopancreatobiliary
      operation, pathology leading to dilated biliary duct, and whose radiological imaging results
      are suitable for modeling. Virtual modeling of pancreaticobiliary pathways of the cases is
      performed and clinical histories of each case were created.

      2.3. Scenarios As a mutual agreement among the specialists in medical education, general
      surgery, anatomy and radiology, 5 cases identified, are elected to be samples for
      pancreaticobiliary surgical processes. Having defined these cases, they are further converted
      into genuine scenarios fully equipped with a past story, medical analysis results and imaging
      procedures.

      Scenarios for 5 cases:

      Case 1. Case with normal extrahepatic biliary tract with pancreas. Case 2. Choledochal tumor
      leading to advanced dilatation and hydropic gallbladder appearance in extrahepatic biliary
      tract.

      Case 3. Acute cholecystitis characterized with extrahepatic biliary dilatation, hydropic
      gallbladder, thickness in gallbladder wall and biliary sludge with multiple millimeter-sized
      stones.

      Case 4. Pancreatic head cancer with severe dilatation in the pancreatic canal and
      extrahepatic biliary tract.

      Case 5. Choledocholithiasis characterized with dilatation at the extrahepatic biliary tract
      and 7 mm diameter stone at the distal end of the common bile duct.

      2.4. Image post-processing and segmentation Original CT images in Digital Imaging and
      Communications in Medicine (DICOM) format are converted to a separate workstation with
      Analyze 12.0 for post-processing and segmentation. A free 3D slicer (version 4.10.1) is
      employed in the process of attaining DICOM output from CT and MRI segments of the patients.
      Special attention is paid to the anatomical structures of the biliary tract including left
      hepatic duct (LHD), right hepatic duct (RHD), and common hepatic duct (CHD) which are
      segmented. The surface condition of the model is enhanced by implementing a softening filter
      to the segmented section output. The output is extracted into STL format to enable 3D
      printing.

      2.5. Creating Life-size Patient-Specific 3D Model 3D printers of Mass Portal Pharaoh xd 20
      and Form Labs2 are employed throughout the process of preparing the models for printing.

      2.6. Quantitative assessment of model accuracy To ensure the model accuracy, measurements of
      the anatomical landmarks are performed and compared at three stages of the model production,
      namely, the original CT images, STL file and 3D model. The internal diameter of four
      anatomical locations is measured from left to right and from anterior to posterior in the
      following landmarks: CHD, LHD, RHD and common bile ducts. .

      2.7. Workshop We performed a systematic review to evaluate of bile tree modelization and 3D
      printing, as well as the proof of concept of the benefit of 3D solid model in planning
      interventions. CT images of a patient diagnosed with dilated extrahepatic ducts are used to
      create the patient-specific, 1-1 scale 3D pancreaticobiliary models including five scenarios
      as the normal anatomy, common bile duct tumor, stony cholecystitis, pancreatic head cancer
      and cholelithiasis. For this purpose, scenarios for each case and a five-station carousel are
      based on the research. For each station, a period of 5-10 minutes is given.

      2.8. Survey Participants' perception of residency training is evaluated with a multi-entry
      survey. In these scenarios, normal pancreaticobiliary organs and cases leading to
      extrahepatic biliary tract dilatation such as choledochal tumor, acute stone cholecystitis,
      pancreatic head tumor and cholelithiasis are discussed. Assessment forms for the normal
      structure of the cases, differential diagnosis and imaging methods in preoperative planning
      and the location of the 3D solid model are prepared. The forms are then asked to be filled by
      the residents to discover their opinions on all models. The evaluaton is done on a scale of
      10, where (01-10) defines 0 = very low and 10 = the highest rank.

      2.9. Statistical analysis Analysis will be submitted into SPSS 24.0 for statistical
      evaluation mean ± standard deviation format is employed for continuous variables. Any
      significant differences in the measurements between the original CT images, 3D-STL images and
      the 3D model are studied by using Wilcoxon Signed Test. Wilcoxon Signed Ranks Test is used to
      determine any significant differences in the measurements between the original CT images,
      3D-STL images and the 3D model. Statistical relevance is stated as a p value of less than
      0.05.
observational model: Case-Control
time perspective: Cross-Sectional
measure: compare the effectiveness of the solid model with CT screen, 3D-Standard Tessellation Language (STL) image and 1:1 scale model
time frame: 30 minute
description: Our aim is to compare the effectiveness of the solid model with CT screen, 3D-Standard Tessellation Language (STL) image and 1:1 scale model in 5 different hepatopancreatobiliary disease scenarios to general surgery residents in terms of recognizing the pathology, differential diagnosis and preoperative preparation stages.
intervention type: Other
intervention name: survey
description: Members chosen for this study group are general surgery residents. A quintet with stations composed of normal pancreaticobiliary anatomy, common bile duct tumor, stony cholecystitis, pancreatic head cancer and cholelithiasis was assembled for the study. Each station contained CT, 3D-STL images and 1:1 solid models of cases. Each imaging method associated with the scenarios of the quintet is observed by the residents of the study. An explanatory assessment measure is being used as data collection method where the perception of each imaging method is being evaluated based on their effectiveness in problem identification as well as their efficiency in diverse diagnosis and pre-surgery organization. Participants' perception of residency training was evaluated with a multi-entry survey. The focus of the survey, which was applied by our team was by domains, self determined decision-making, diverse diagnosis, academic scholarship, and scientific appraisal.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 24 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Muhtar S Ersin, Prof. Dr
role: Study Chair
affiliation: Faculty of Medicine, Ege University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ege University
investigator full name: Figen GOVSA
investigator title: Prof. Dr, Senior investigator
mesh term: Intraoperative Complications
sharing ipd: No
ipd description: Our aim is to compare the effectiveness of the solid model with CTimage, 3Dimage and 3Dmodel in 5 different hepatopancreatobiliary disease scenarios presented to general surgery residents in terms of recognizing the pathology, differential diagnosis and preoperative preparation stages. The focus of the survey applied by our team was on domains, decision-making, diverse diagnosis, scientific appraisal. In these scenarios, normal pancreaticobiliary organs and cases leading to extrahepatic biliary tract dilatation such as choledochal tumor, acute stone cholecystitis, pancreatic head tumor and cholelithiasis were discussed. Perception of the anatomical formation, impact of the procedure to diverse diagnosis, operation arrangement and presurgical preparation assistance are the main criteria in the evaluation of every imaging procedure. Any significant differences in the measurements between the CTimages, 3Dimages and the 3Dmodel were obtained by using Wilcoxon Signed Test.