Educational ProblemsNCT04395235
Perceptions of Porta Celiac Vascular Model
A study testing Survey in people with Educational Problems, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Educational Problems
- What is being tested?
- Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2018to 5 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ethical Committee at Researches of Ege University
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.
Read the detailed description
2.1. Research Design The study group consisted of Ege University, Faculty of Medicine general surgery residents (n:22). A five-station carousel composed of vascular patterns such as classical porta-celiac, portal vein type 2, portal vein type 3, separate branches origin of celiac trunk and portal vein pattern located between the right and the left hepatic artery. Each station contained the CT, and life size models of the cases. As data collection tool, a descriptive rating scale was used to evaluate the perceptions of each of the methods (CT and 3D solid model) in terms of their usefulness in knowing the variations, perceiving the problem, their effectiveness in differential diagnosis and preoperative planning.
Arterial variations were classified according to previous authors. In the classical anatomy, the common hepatic artery arises from the celiac trunk to form the gastroduodenal and proper hepatic arteries, and the latter dividing distally into right and left branches. Separate branches origin of the celiac trunk such as the artery from the abdominal aorta were modeled individually in cases of variant neighborhood. Portal variations were classified as the portal vein types. Type 1 is the classical appearance, in which the right portal vein and left portal are present as independent trunks. In type 2, the right anterior portal vein, right posterior portal vein, and left portal vein trifurcate from the main portal vein. In type 3, the right posterior portal vein comes directly from the middle portal vein, and the left portal vein and right anterior portal vein emerge from a common trunk.
The study was approved by the suitably constituted Ethical Committee at Researches Department of Ege University (18-5/45), within which the work was undertaken, and the study conforms to the Declaration of Helsinki. Clinicaltrails number is EGE18-6.134.
2.2. Selection of the samples The patients in this study were chosen among the ones who consulted to Ege University Faculty of Medicine, Department of General Surgery, Hepatobiliary Surgery and Transplantation Division for diagnose between September 2016 and January 2018. CT archives were screened and 100 eligible people (age: 18-62) with porta-celiac vascular patterns were selected. Patients whose radiological imaging results were suitable for modeling and the ones with no previous operation or pathology that may cause anatomical differences were included in the study.
2.3. Stations Five case carousel that could serve as an example for variational hepatic vascularity was defined with the consensus of experts in medical education, anatomy, radiology and liver transplantation team. The carousel included the following 5 cases.
Case 1. Portal vein with Type 3 classification pattern. Case 2. Normal classification porta-celiac vascular pattern. Case 3. Vascular pattern with the separate branch origin of celiac trunk. Case 4. Portal vein between the right and the left hepatic artery. Case 5. Portal vein with Type 2 classification pattern. 2.4. Image post-processing and segmentation DICOM data from CT and MRI sections of the patients were obtained using free 3D Slicer (version 4.10.1) software. Segmentations of the portal vein, hepatic vein, splenic vein were automatically generated from the venous phase, while the celiac trunk and hepatic artery were manually traced from the arterial phase.
2.5. Creating life-size patient-specific porta-celiac vascular model 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. Model production took a total of 24 hours; 4 for segmentation, 3 for editing, 15 for printing, and 1 hour for post-print processing. Arterial vessels were color-coded red, and the portal vein blue by the visualization team.
2.6. Quantitative assessment of model accuracy Measurements of the anatomical structures were performed and compared between the original CT images, and the CT images of the 3D model. The morphometric values such as inter-arterial distances (distances between arterial origins), inter-venous distances and the distance between the artery and the vein were noted. Measurements were compared for original CT images, the 3D rendered files, and the 3D vascular models. The repetition rate of the measurements which were done by two autonomous spectators, was 3 times at every scene and the mean values were taken as ultimate output and also calculated for further statistical analysis. The spectators performed with exceptional correlation (r=0.99, P<0.001).
2.7. Workshop During the workshop, 30-minute lectures were given by the expert team on variable vascular pattern, arterial structures relationship with venous structures and models in diagnosis. For each station, a period of 5-10 minutes was given.
2.8. Survey 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.
2.9. Statistical analysis Data are entered into SPSS 24.0 for statistical analysis. Continuous variables were presented as mean ± standard deviation. 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.
- Conditions
- Educational Problems
- Being tested
- Survey
- Keywords
- Patient-specific modelling, Graduate surgical education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Targeted Surgical Therapy Plan | Experimental | This 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. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 05.10. 2019, 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start5 May 2018
- Primary completion5 Nov 2018
- Study completion5 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Figen GOVSA, Ege University
- Investigators
- Mehmet Ozer, Prof. Dr, Study chair, Faculty of Medicine, Ege UniversityYelda Pinar, Study chair, Faculty of Medicine, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395235
- Sponsor's protocol ID
- EGE18-5/45
- Status last verified
- May 2020
- First submitted
- 25 Apr 2020
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethical Committee at Researches of Ege University
- ClinicalTrials.gov ID
- NCT04395235
- Acronym / sponsor ID
- EGE18-5/45
- Conditions
- Educational Problems
- Keywords
- Patient-specific modelling, Graduate surgical education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 5 May 2018 (actual)
- Primary completion
- 5 Nov 2018 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 20 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
2.1. Research Design The study group consisted of Ege University, Faculty of Medicine general surgery residents (n:22). A five-station carousel composed of vascular patterns such as classical porta-celiac, portal vein type 2, portal vein type 3, separate branches origin of celiac trunk and portal vein pattern located between the right and the left hepatic artery. Each station contained the CT, and life size models of the cases. As data collection tool, a descriptive rating scale was used to evaluate the perceptions of each of the methods (CT and 3D solid model) in terms of their usefulness in knowing the variations, perceiving the problem, their effectiveness in differential diagnosis and preoperative planning.
Arterial variations were classified according to previous authors. In the classical anatomy, the common hepatic artery arises from the celiac trunk to form the gastroduodenal and proper hepatic arteries, and the latter dividing distally into right and left branches. Separate branches origin of the celiac trunk such as the artery from the abdominal aorta were modeled individually in cases of variant neighborhood. Portal variations were classified as the portal vein types. Type 1 is the classical appearance, in which the right portal vein and left portal are present as independent trunks. In type 2, the right anterior portal vein, right posterior portal vein, and left portal vein trifurcate from the main portal vein. In type 3, the right posterior portal vein comes directly from the middle portal vein, and the left portal vein and right anterior portal vein emerge from a common trunk.
The study was approved by the suitably constituted Ethical Committee at Researches Department of Ege University (18-5/45), within which the work was undertaken, and the study conforms to the Declaration of Helsinki. Clinicaltrails number is EGE18-6.134.
2.2. Selection of the samples The patients in this study were chosen among the ones who consulted to Ege University Faculty of Medicine, Department of General Surgery, Hepatobiliary Surgery and Transplantation Division for diagnose between September 2016 and January 2018. CT archives were screened and 100 eligible people (age: 18-62) with porta-celiac vascular patterns were selected. Patients whose radiological imaging results were suitable for modeling and the ones with no previous operation or pathology that may cause anatomical differences were included in the study.
2.3. Stations Five case carousel that could serve as an example for variational hepatic vascularity was defined with the consensus of experts in medical education, anatomy, radiology and liver transplantation team. The carousel included the following 5 cases.
Case 1. Portal vein with Type 3 classification pattern. Case 2. Normal classification porta-celiac vascular pattern. Case 3. Vascular pattern with the separate branch origin of celiac trunk. Case 4. Portal vein between the right and the left hepatic artery. Case 5. Portal vein with Type 2 classification pattern. 2.4. Image post-processing and segmentation DICOM data from CT and MRI sections of the patients were obtained using free 3D Slicer (version 4.10.1) software. Segmentations of the portal vein, hepatic vein, splenic vein were automatically generated from the venous phase, while the celiac trunk and hepatic artery were manually traced from the arterial phase.
2.5. Creating life-size patient-specific porta-celiac vascular model 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. Model production took a total of 24 hours; 4 for segmentation, 3 for editing, 15 for printing, and 1 hour for post-print processing. Arterial vessels were color-coded red, and the portal vein blue by the visualization team.
2.6. Quantitative assessment of model accuracy Measurements of the anatomical structures were performed and compared between the original CT images, and the CT images of the 3D model. The morphometric values such as inter-arterial distances (distances between arterial origins), inter-venous distances and the distance between the artery and the vein were noted. Measurements were compared for original CT images, the 3D rendered files, and the 3D vascular models. The repetition rate of the measurements which were done by two autonomous spectators, was 3 times at every scene and the mean values were taken as ultimate output and also calculated for further statistical analysis. The spectators performed with exceptional correlation (r=0.99, P<0.001).
2.7. Workshop During the workshop, 30-minute lectures were given by the expert team on variable vascular pattern, arterial structures relationship with venous structures and models in diagnosis. For each station, a period of 5-10 minutes was given.
2.8. Survey 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.
2.9. Statistical analysis Data are entered into SPSS 24.0 for statistical analysis. Continuous variables were presented as mean ± standard deviation. 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.
Study design
- Primary purpose
- Basic science
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Targeted Surgical Therapy Plan | Experimental | Other: SurveyThis 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. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyA 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). | Other | Targeted Surgical Therapy Plan |
Primary outcome
Creating life-size patient-specific porta-celiac vascular model
Time frame: 05.10. 2019, 45 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Ozer, Prof. Dr study chair
Faculty of Medicine, Ege University
Yelda Pinar study chair
Faculty of Medicine, Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey in people with Educational Problems, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creating life-size patient-specific porta-celiac vascular model (time frame: 05.10. 2019, 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.