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Perceptions of Porta Celiac Vascular Model

15 de mayo de 2020 actualizado por: Figen GOVSA, Ege University

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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

22

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • İzmir, Pavo, 35120
        • Ege university

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

25 años a 35 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria: General Surgery Resident -

Exclusion Criteria: General Surgery Specialist

-

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Targeted Surgical Therapy Plan
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.
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).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Creating life-size patient-specific porta-celiac vascular model
Periodo de tiempo: 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.
05.10. 2019, 45 minutes

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Silla de estudio: Mehmet Ozer, Prof. Dr, Faculty of Medicine, Ege University
  • Silla de estudio: Yelda Pinar, Faculty of Medicine, Ege University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

5 de mayo de 2018

Finalización primaria (Actual)

5 de noviembre de 2018

Finalización del estudio (Actual)

5 de agosto de 2019

Fechas de registro del estudio

Enviado por primera vez

25 de abril de 2020

Primero enviado que cumplió con los criterios de control de calidad

15 de mayo de 2020

Publicado por primera vez (Actual)

20 de mayo de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de mayo de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

15 de mayo de 2020

Última verificación

1 de mayo de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • EGE18-5/45

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Marco de tiempo para compartir IPD

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.

Criterios de acceso compartido de IPD

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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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