Perceptions of Porta Celiac Vascular Model
Ethical Committee at Researches of Ege University
1 other identifier
interventional
22
1 country
1
Brief Summary
Background: Primary aspect of hepatic navigation surgery is the identification of source vascular details to preserve healthy liver which has a vascularity anatomy quite challenging for the young surgeons. The purpose was to determine whether three-dimensional (3D) vascular pattern models of preoperative computed tomography images will assist resident-level trainees for hepatic surgery. Methods: This study was based on the perception of residents who were presented with 5 different hepatic source vascular pattern and required to compare their perception level of CT, and 1:1 models in terms of importance of variability, differential of patterns and preoperative planning. Results: All subspecialties agree that models provided better understanding of vascular source and improved preplanning. Five stations provided qualitative assessment with results showing the usefulness of porta-celiac models when used as anatomical tools in preplanning (p=0.04), simulation of interventional procedures (p=0.02), surgical education (p=0.01). None of the cases a scored less than 8.5. Responses related to understanding variations were significantly higher in the perception of the 3D model in all cases, furthermore 3D models were more useful for seniors in more complex cases 3 \& 5. Some open-ended answers: "The 3D model can completely change the operation plan" One the major factors for anatomical resection of liver transplantation is the positional relationship between the hepatic arteries and the portal veins. Conclusions: The plastic-like material presenting the hepatic vascularity enables the visualization of the origin, pattern, shape, and angle of the branches with appropriate spatial perception thus making the well-structured.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 5, 2019
CompletedFirst Submitted
Initial submission to the registry
April 25, 2020
CompletedFirst Posted
Study publicly available on registry
May 20, 2020
CompletedMay 20, 2020
May 1, 2020
6 months
April 25, 2020
May 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Creating life-size patient-specific porta-celiac vascular model
The survey was utilized by our group, understanding of patient vascular anatomy, awareness of the changes based on variations, independent decision-making, differential diagnosis, plan on key surgical steps, and preparation for unexpected bleeding.
05.10. 2019, 45 minutes
Study Arms (1)
Targeted Surgical Therapy Plan
EXPERIMENTALThis study pointed out that 3D surgico-anatomical models lead to more precise anatomical understanding compared to CT images in terms of detail perception. The 3D models of vascular patterns proves to be the optimal design according to the experts' evaluation with its teaching effects on surgical residents. The demonstration of the hepatic source vascular anatomy and corresponding vascular patterns may provide practically useful guides in decision making related to vascular detail during living donor liver transplantation.Model CT's were measured in order to verify 1:1 modelling and the printing the process was carried out with 3D printers of Mass Portal Pharaoh xd 20 with Eryone PLA 3D printer flament (2.2LBS)/Spool, White). Measurements of the anatomical structures were compared between the original CT images, and the CT images of the 3D model. The morphometric values such as inter-arterial distances, inter-venous distances and the distance between artery and vein were noted.
Interventions
A multi-item survey was prepared to assess fellow's perception of residency training. The survey was utilized by our group, understanding of patient vascular anatomy, awareness of the changes based on variations, independent decision-making, differential diagnosis, plan on key surgical steps, and preparation for unexpected bleeding. The answers to the questions asked for each case were analyzed to include senior (3 years and over) - junior (1-2 years) residents.Assistants spend 45 minutes in the survey. Data are entered into SPSS 24.0 for statistical analysis. Wilcoxon Signed Ranks Test was used to determine any significant differences in the measurements between the original CT images, 3D rendered images, the 3D model and CT images of the 3D model. Statistical significance was defined as a p value of less than 0.05. Junior assistants stated that they perceived 2D image statistically better than 3D models compared to the senior assistants (Kruskal-Wallis Test).
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ege Universitylead
Study Sites (1)
Ege University
Izmir, 35120, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mehmet Ozer, Prof. Dr
Faculty of Medicine, Ege University
- STUDY CHAIR
Yelda Pinar
Faculty of Medicine, Ege University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr, Senior investigator
Study Record Dates
First Submitted
April 25, 2020
First Posted
May 20, 2020
Study Start
May 5, 2018
Primary Completion
November 5, 2018
Study Completion
August 5, 2019
Last Updated
May 20, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Current surgical planning primarily relies on the surgeon's ability to interpret and mentally reconstruct two-dimensional (2D) CT images into 3D while planning resection margins. Although surgeons do convert what they see on flat monitors into a 3D mental design with intraoperatively expected details, each case differs from the other and 2D images are not sufficient to provide a comprehensive viewing of the vasculo-anatomical details.
- Access Criteria
- This will help liver transplantation team surgeons to review the most common hepatic vascular anatomy, allowing the simultaneous visualization in addition to providing the professionals with the material to be used in pedagogical curriculum.
The aim was to assess whether the 3D models could be more informative than the standard CT images in predicting the real cases with different patterns. We also aimed to compare the effectiveness of the life-size model with CT screen, in 5 different porta-celiac variational cases for hepatic surgery to general surgeon residents in terms of recognizing the variational vascular source, differential diagnosis and preoperative preparation stages. It also targets to evaluate the use of these models in training and proficiency exams.