Surgical Planning With Patient-specific Pancreaticobiliary Disease With 3D Models
Condition: Surgical Injury
MeSH terms: Intraoperative Complications
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): survey
Intervention type(s): Other
Intervention description(s): 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.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Members chosen for this study group are general surgery residents present in Faculty of
        Medicine, Ege University
      
Keywords: Graduate medical education; Personalized medicine