Value of 3D Printing for Comprehension of Liver Surgical Anatomy

January 13, 2018 updated by: Tianyou Yang, Guangzhou Women and Children's Medical Center
To our knowledge, it has not been analyze whether 3D printed liver model would improve the perception of a given liver tumor or the precision of operation planning in liver surgery. We design this prospective controlled trial to test whether the 3D-printed patient specific liver model could be more informative than standard MDCT (multi-row detector computed tomography ) and 3D visualization system in predicting the surgical anatomy of liver.

Study Overview

Status

Completed

Conditions

Detailed Description

The primary objective was to investigate whether 3D printing can improve localization of hepatic pathology. The secondary objective was to investigate whether 3D printing can improve the precision of surgical proposal.

The dataset of patients were prepared and stratified into MDCT, 3D visualization system and 3D printed liver model groups. The process started from MDCT scan image acquisition and moved through image segmentation and 3D rendering to end up with 3D printing.

Surgical residents were assigned to three different groups to study different modes of patients' data. Residents were ask to state the liver segment in which the tumor resides and make a minimal resection proposal, including the tumor, the safety margin (1cm) and the dependent liver tissue. Residents were recommended to proceed in a classic way by resecting the whole liver segment. The time spent by each resident was also recorded in order to assess the quickness of comprehension and information transfer of the three different modes of presentation.

Study Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Guangdong
      • Dongguan, Guangdong, China
        • he Fifth People's Hospital of Dongguan City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Medical students had to finish five year medical school education (including one year internship), and then went into at least 3 year training program for surgical residency. Those who had finished training of general surgery were the study population.

Description

Inclusion Criteria:

  • Surgical residents
  • Must had experiences with MDCT and 3D visualization system

Exclusion Criteria:

  • Non surgical residents
  • No experiences with MDCT or 3D visualization system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MDCT group
The MDCT images of seven hepatic tumors were loaded on software to uniform study conditions, allowing both axial and coronal scans visualization.
Surgical residents were assigned to three different groups to evaluate different modes of patients' data. Residents were ask to state the liver segment in which the tumor resided and make a minimal resection proposal, including the tumor, the safety margin (1cm) and the dependent liver tissue. Residents were recommended to proceed in a classic way by resecting the whole liver segment. The time spent by each resident was also recorded in order to assess the quickness of comprehension and information transfer of the three different modes of presentation.
3D visualization system group
The 3D virtual reconstructions of seven hepatic tumors were loaded on the visualization software which enables the rotation of the virtual model.
Surgical residents were assigned to three different groups to evaluate different modes of patients' data. Residents were ask to state the liver segment in which the tumor resided and make a minimal resection proposal, including the tumor, the safety margin (1cm) and the dependent liver tissue. Residents were recommended to proceed in a classic way by resecting the whole liver segment. The time spent by each resident was also recorded in order to assess the quickness of comprehension and information transfer of the three different modes of presentation.
3D printing group
3D-printed models of seven hepatic tumors were created based on MDCT images, participants were allowed to freely handle them.
Surgical residents were assigned to three different groups to evaluate different modes of patients' data. Residents were ask to state the liver segment in which the tumor resided and make a minimal resection proposal, including the tumor, the safety margin (1cm) and the dependent liver tissue. Residents were recommended to proceed in a classic way by resecting the whole liver segment. The time spent by each resident was also recorded in order to assess the quickness of comprehension and information transfer of the three different modes of presentation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcomes was the precise allocation of hepatic disease
Time Frame: The primary outcome was assessed within 1 week after the collection of each participants' response.
For tumor allocation to the liver segments, 8 points were awarded if all segments were correctly identified in which the tumors resided. If the tumors was located in more than one segment, the 8 maximal achievable points were divided between these segments. Erroneously identified segments were awarded 0 point. Alternatively, the primary outcomes were also simply judged as right or wrong according to the final surgical results.
The primary outcome was assessed within 1 week after the collection of each participants' response.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resection proposal of liver pathology
Time Frame: The secondary outcome was assessed within 1 week after the collection of each participants' response.
he resection proposals on the liver were compared with surgical results that had been evaluated by surgeons and judged by the formula mentioned earlier.
The secondary outcome was assessed within 1 week after the collection of each participants' response.
Time spent to judge tumor location
Time Frame: The secondary outcome was assessed within 1 week after the collection of each participants' response.
The time spend to assess tumor location by each resident was documented as seconds
The secondary outcome was assessed within 1 week after the collection of each participants' response.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tianyou Yang, MD, Guangzhou Women and Children's Medical Center, Guangzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

January 10, 2018

Study Completion (Actual)

January 10, 2018

Study Registration Dates

First Submitted

May 6, 2017

First Submitted That Met QC Criteria

May 12, 2017

First Posted (Actual)

May 15, 2017

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 13, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 3D printing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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