NCT04395235

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

April 25, 2020

Last Update Submit

May 15, 2020

Conditions

Keywords

Patient-specific modellingGraduate surgical education

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

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.

Other: Survey

Interventions

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).

Targeted Surgical Therapy Plan

Eligibility Criteria

Age25 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, 35120, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Mehmet Ozer, Prof. Dr

    Faculty of Medicine, Ege University

    STUDY CHAIR
  • Yelda Pinar

    Faculty of Medicine, Ege University

    STUDY CHAIR

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

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.

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.

Locations