Surgical Injury Clinical Trial
Official title:
Ethical Committee at Researches of Ege University
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.
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